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This will be the first study to investigate the use of rTMS in the treatment of neuropathic pain in pregnancy. This study will enroll 60 pregnant subjects, age 18-45. All participants will receive treatment as usual. Subjects diagnosed with neuropathic pain will be offered rTMS as a treatment option.
Neuropathic pain is a common pain disorder that is caused by problems in the nervous system. It affects more women than men and commonly occurs in pregnancy. Physicians have little information to guide their treatment of neuropathic pain in pregnancy. The overall goal of this study is to define the course, management, and pregnancy outcomes of neuropathic pain in pregnancy and the acute postpartum period. It is difficult to manage neuropathic pain in pregnancy as treatment options must minimize their risk to the unborn child as they have a direct effect on infant outcomes through their exposure in utero. Thus, other treatments are needed. Repetitive transcranial magnetic stimulation (rTMS) may be an acceptable alternative to medications. Transcranial magnetic stimulation uses a magnetic force to change the way nerves work in the brain. This non-invasive and localized mechanism of action makes it attractive for use in special populations, such as pregnancy. Study visits will occur approximately every 4-6 weeks during pregnancy until approximately 3 months postpartum for a maximum of 12 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - Neuropathic Pain | Other | Subjects with a score of ≥ 13 on the painDETECT Questionnaire (PDQ) will be assigned to the Neuropathic Pain group. |
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| Part A - Non-Neuropathic Pain | Other | Subjects with a score of ≥ 1 or ≤ 12 on the painDETECT Questionnaire (PDQ) will be assigned to the Non-Neuropathic Pain group. |
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| Part A - Control | Other | Subjects with a score of score = 0 on the painDETECT Questionnaire (PDQ) will be assigned to the Control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| painDETECT Questionnaire | Behavioral | This self-report questionnaire consists of 7 questions that address the quality of neuropathic pain syndromes. The first 5 questions ask about the gradation of pain, question 6 asks about the pain course pattern and question 7 asks about radiating pain. There are 4 additional questions (not counted in the total score) which asks the subject to rate their pain now and over the last 4 weeks and to mark on a body chart if there is pain radiating into other parts of the body. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Visual Analogue Scale for Pain | 100 mm line scale that is subject administered to subjectively rate current pain symptoms. The subject will be instructed to draw a single vertical line that best describes current state. The total score ranges from 0-100 with higher numbers indicating worse outcomes. The VAS will be administered at every subject visit. | Baseline and end of study participation, an average of 194 days |
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Part A
Inclusion Criteria:
Exclusion Criteria:
Part B
Inclusion Criteria:
Subjects enrolled in Part A and willing to consent to Part B of this protocol
Pregnant with current chronic neuropathic pain
Subjects failed treatment with amitriptyline or nortriptyline as defined by one of the following:
Subjects must pass the TMS Safety Checklist Adult Safety Screen (TASS).
Subjects should be off medication, which can lower seizure thresholds (e.g., amitriptyline and nortriptyline) for at least two weeks prior to study entry.
Subjects with neuropathic pain including those with diagnosis of spinal cord injury, fibromyalgia, compression neuropathies (including diabetic peripheral neuropathy), post stroke pain, and multiple sclerosis
Subjects with a baseline VAS score greater than 30
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shona L Ray-Grififth, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas For Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Neuropathic Pain Group | ≥13 on the painDETECT Questionnaire (PDQ) 10 subjects |
| FG001 | Part A: Non-Neuropathic Pain Group | ≥1 and ≤12 on the PDQ 5 subjects |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2021 | Apr 19, 2021 |
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All subjects will participate in Part A, receive standard of care and complete the painDETECT Questionnaire (PDQ) to be assigned to 1 of 3 groups based on the PDQ score.
Subjects in Part A will complete the following at study entry and each study visit: the Beck Depression Inventory (BDI), Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), and measures of pain intensity, interference, behavior. At each visit after study entry, subjects will complete the Patients' Global Impression of Change scale (PGIC); clinicians will complete the Clinical Global Impression-Global Improvement scale (CGI-I).
Subjects in Part B will receive rTMS and be followed daily until day 29 after last rTMS session. For each session, subjects will complete a VAS prior, immediately after, and 60 minutes post, day 22 & day 29; a BDI on Days 1, 5, 12, 22, & 29; on days 5, 12, 22, & 29 subjects will complete the PGIC; clinicians will complete the CGI-I.
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| Part B - rTMS |
| Experimental |
Subjects from the Neuropathic Pain group will be invited to participate in the Part B rTMS group to receive repetitive transcranial magnetic stimulation (rTMS). |
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| Pain Catastrophizing Scale | Behavioral | The PCS is a 13-item self-report scale. It asks subjects to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification, and helplessness. |
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| Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale | Behavioral | The 3-item, self-report Pain Intensity assesses how much a person hurts. The first 2 items assess pain intensity over the past 7 days; the last item asks subject to rate pain intensity "right now." The 4-item, self-report Pain Interference measures the consequences of pain on relevant aspects of subject's life. It includes impairment in subject's social, cognitive, emotional, physical, & recreational activities. It also incorporates items about sleep and enjoyment of life. It assesses pain interference over the past 7 days. The 7-item, self-report Pain Behavior measures behaviors that typically indicate to others that an individual is experiencing pain. Measures include observations (sighing, crying), behaviors (resting, guarding, facial expressions, asking for help), & verbal reports of pain. It assesses pain interference over the past 7 days. All three scales, derived from the Patient Reported Outcomes Measurement Information System (PROMIS), are not disease specific. |
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| Beck Depression Inventory | Behavioral | The BDI is a widely used instrument that has been used in both clinical and non-clinical setting measuring depressive symptoms. It is a 21 item questionnaire with 4-5 responses for each question. Responses are coded 0-3 for the 4 point scales. The 5 point scales include an additional 2a and 2b response code. The symptom categories reflect overt behavioral manifestations of depression. The instrument has both a high degree of reliability and validity (Beck, Ward, Mendelson, Mock & Erbaugh, 1961). |
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| Visual Analogue Scale | Behavioral | 100 mm line scale that is subject administered to subjectively rate current pain symptoms. The subject will be instructed to draw a single vertical line that best describes current state. |
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| Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale | Behavioral | The PGIC gives a global rating of change in symptoms, activities, emotion, and overall quality of life related to the subject's pain condition. This is a self-rated scale. The CGI-I gives a global rating of the improvement/change in the symptoms since the last study visit. This is administered by the MD. |
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| Transcranial Magnetic Stimulation | Device | Subjects will undergo daily repetitive transcranial magnetic stimulation (rTMS), defined as Monday through Friday, for a total of 10 consecutive sessions. rTMS will be applied using the NeuroStar TMS Therapy System through a figure-8 coil connected to a magnetic stimulator, which provides a biphasic pulse. The coil is applied to the primary motor cortex, M1, contralateral to the painful side. The optimal stimulus site, motor hot spot, will be determined according to visual detection of muscle twitches, and a resting motor threshold is defined as the minimal intensity necessary to induce at least one visible muscle twitch. An rTMS session consists of 10 trains at 90% intensity of resting motor threshold (one train, 100 pulses at 10 Hz; intertrain interval, 50s). |
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| FG002 | Part A: Controls | Patients without neuropathic pain receiving care as usual. |
| FG003 | Part B Participants | No participants were ever enrolled in Part B, so this group has been dropped from all future sections. |
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| NOT COMPLETED |
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0 subjects met criteria to be assigned to the "control" group
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| ID | Title | Description |
|---|---|---|
| BG000 | Neuropathic Pain Group | ≥13 on the painDETECT Questionnaire (PDQ) |
| BG001 | Non-Neuropathic Pain Group | score of ≥1 or ≤12 on the PDQ |
| BG002 | Controls | Patients without neuropathic pain receiving care as usual. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Visual Analogue Scale for Pain | 100 mm line scale that is subject administered to subjectively rate current pain symptoms. The subject will be instructed to draw a single vertical line that best describes current state. The total score ranges from 0-100 with higher numbers indicating worse outcomes. The VAS will be administered at every subject visit. | No subjects were ever assigned to the control group, so no stats were performed on this group | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and end of study participation, an average of 194 days |
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Average length of study participation: 194 days; Range: 112-259 days
None of the subjects met criteria to be assigned to the "control" group
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neuropathic Pain Group | score of ≥13 on the PDQ Total Serious Adverse Events: 6 Number of Participants Affected by Serious Adverse Events: 3 Total Adverse Events: 62 Number of Participants Affected by Adverse Events: 8 | 0 | 10 | 3 | 10 | 8 | 10 |
| EG001 | Non-Neuropathic Pain Group | score of ≥ 1 or ≤ 12 on the PDQ Total Serious Adverse Events: 40 Number of Participants Affected by Serious Adverse Events: 3 Total Adverse Events: 39 Number of Participants Affected by Adverse Events: 5 | 0 | 5 | 3 | 5 | 5 | 5 |
| EG002 | Controls | score of 0 on the PDQ Total Serious Adverse Events: 0 Number of Participants Affected by Serious Adverse Events: 0 Total Adverse Events: 0 Number of Participants Affected by Adverse Events: 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Intubated, ventilator support, NICU |
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| Hypoglycemia | Endocrine disorders | Systematic Assessment | Glucose given, NICU |
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| Patent Ductus Arteriosus | Cardiac disorders | Systematic Assessment | Admitted to NICU, given ECHO |
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| Hyperbilirubinemia | Hepatobiliary disorders | Systematic Assessment | Start date: 8/28/2019 End date: Ongoing 4 - Unrelated to Study Device 5- Intervention Phototherapy |
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| Severe Retro-Micrognathia with Critical Airway | Musculoskeletal and connective tissue disorders | Systematic Assessment | Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5- Intervention Tracheotomy |
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| Microtia | Congenital, familial and genetic disorders | Systematic Assessment | Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Intervention CT Scan & Hearing evaluations |
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| Microstomia | Congenital, familial and genetic disorders | Systematic Assessment | Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Placed gastrostomy tube & CT Scan |
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| Vertebral Anomalies | Musculoskeletal and connective tissue disorders | Systematic Assessment | Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Chest X-Rays & consulted orthopedics |
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| Infection of Tracheotomy | Infections and infestations | Systematic Assessment | Start Date: 09/24/2017 End Date: 9/30/2017 4 - Unrelated to Study Device 5 - antibiotics & culture |
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| Acinetobacter Infection of GT site | Infections and infestations | Systematic Assessment | Start Date: 10/20/2017 End Date: 10/30/2017 4 - Unrelated to Study Device 5 - cultured infection & antibiotics |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment | Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - placed gastrostomy tube & speech therapy evaluation |
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| Cleft Palate | Congenital, familial and genetic disorders | Systematic Assessment | Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - discovered 5/4/2018 in clinical exam |
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| Bilateral superior vena cava without bridging vein | Congenital, familial and genetic disorders | Systematic Assessment | Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - admitted to NICU & given ECHO |
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| Shortened Femurs | Musculoskeletal and connective tissue disorders | Systematic Assessment | Start Date: 8/28/2017 End Date: Ongoing |
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| Bilateral Club Feet | Congenital, familial and genetic disorders | Systematic Assessment | Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 1 - discovered in clinical exam |
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| Teratologic Hips | Musculoskeletal and connective tissue disorders | Systematic Assessment | Start Date: 9/1/2017 End Date: Ongoing 4 - Unrelated to Study Device 1 - discovered by abdominal x-ray |
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| Glossoptosis | Congenital, familial and genetic disorders | Systematic Assessment | Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - gastrostomy feeding tube |
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| Medical neglect of child by caregiver | Social circumstances | Systematic Assessment | Start Date: 11/21/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - DHS Report |
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| Cardiopulmonary arrest with successful resuscitation | Cardiac disorders | Systematic Assessment | Start Date: 12/06/2017 End Date: 12/06/2017 4 - Unrelated to Study Device 5 - CPR |
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| Moraxella catarrhalis & HFLU Pneumonia | Infections and infestations | Systematic Assessment | Start Date: 12/04/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Culture & antibiotics |
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| Hypochloremia | Blood and lymphatic system disorders | Systematic Assessment | Start Date: 11/26/2017 End Date: 12/06/2017 4 - Unrelated to Study Device 5 - IV fluids & medications |
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| Hyperactive Delirium | Psychiatric disorders | Systematic Assessment | Start Date: 11/20/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Medications for Sedation |
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| Rhinovirus Bronchitis | Infections and infestations | Systematic Assessment | Start Date: 11/21/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - medication |
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| Preeclampsia | Reproductive system and breast disorders | Systematic Assessment | Start Date: 11/10/2016 End Date: 11/10/2016 4 - Unrelated to Study Device 5 - Emergency C-section |
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| Jaundice | Hepatobiliary disorders | Systematic Assessment | Start Date: 11/10/2016 End Date: 11/12/2016 4 - Unrelated to Study Device 5 - NICU Admission |
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| Pre-Term Labor | Reproductive system and breast disorders | Systematic Assessment | Start Date(s): 03/04/2017; 01/10/2017 End Date(s): 03/04/2017; 01/11/2017 4 - Unrelated to Study Device 5 - Emergency C-section |
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| Incision Infection | Infections and infestations | Systematic Assessment | Start Date: 03/04/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Surgery & Wound Care |
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| Bronchitis | Infections and infestations | Systematic Assessment | Start Date: 12/08/2016 End Date: 02/16/2017 4 - Unrelated to Study Device 5 - Antibiotic, cough syrup, admission to hospital |
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| Hellp Syndrome (Atypical) | Reproductive system and breast disorders | Systematic Assessment | Start Date: 04/15/2017 End Date: 04/20/2017 4 - Unrelated to Study Device 5 - Hospital & Nifedipine |
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| Neonatal Abstinence Syndrome | Social circumstances | Systematic Assessment | Start Date(s): 04/15/2017; 04/15/2017 End Date(s): 04/29/2017; 04/29/2017 4 - Unrelated to Study Device 5 - NICU Admission |
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| Meconium Aspiration | Infections and infestations | Systematic Assessment | Start Date: 04/20/2017 End Date: 04/22/2017 4 - Unrelated to Study Device 5 - NICU Admission |
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| Transient Trachypnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Start Date: 04/20/2017 End Date: 04/22/2017 |
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| Metabolic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| seizure-like activity | Nervous system disorders | Systematic Assessment |
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| Premature Rupture of Membranes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Preterm Delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Patent foramen ovale | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Severe Retro-Micrognathia with critical airway | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain Increase | Nervous system disorders | Systematic Assessment | Start Date(s): 10/27/2016; 12/01/2016; 11/17/2016; 12/22/2016; 02/16/2017; 11/17/2016; 07/13/2017; 12/01/2016; 12/01/2016; 04/06/201; 06/01/2017; 04/13/2017; 05/11/2017; 05/18/2017; 08/10/2017 |
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| Headaches | Nervous system disorders | Systematic Assessment | Start Date(s): 11/17/2016; 06/05/2017;02/13/2017; 04/27/2017; 11/03/2016;12/01/2016; 06/01/2017; 05/18/2017; 08/03/2017 4 - Unrelated to Study Device 3 - Resolved / Recovered |
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| Anesthesia Difficulty | Nervous system disorders | Systematic Assessment | Start Date: 12/16/2016 End Date: 12/16/2016 4 - Unrelated to study device 1 - Recovered / Resolved |
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| Depressed Mood | Psychiatric disorders | Systematic Assessment | Start Date(s): 10/27/2016; 09/22/2016; 07/13/2017; 05/26/2017; 12/01/20160; 6/01/2017; 06/08/2017; 04/13/2017; 05/18/2017; 07/13/2017; 08/10/2017f 4 - Unrelated to study device 2 - recovering / resolving |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment | Start Date(s): 01/26/2017; 12/22/2016 End Date(s): Ongoing 4 - Unrelated to study device 3 - Not recovered / resolved |
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| Dry Mouth | Blood and lymphatic system disorders | Systematic Assessment | Start Date: 01/26/2017 End Date: Ongoing 4 - Unrelated to Study Device 3 - Not recovered / resolved |
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| Dizzy Spells | Metabolism and nutrition disorders | Systematic Assessment | Start Date: 02/23/2017 End Date: Ongoing 4 - Unrelated to study device 2 - Recovering / Resolving |
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| Vision Changes | Eye disorders | Systematic Assessment | Start Date: 11/17/2016 End Date: 12/16/2016 4 - Unrelated to Study Device 1- Recovered / Resolved |
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| Nausea | Gastrointestinal disorders | Systematic Assessment | Start Date(s): 02/23/2017; 11/03/2016; 11/17/2016; 08/31/2016; 02/16/2017; 12/01/2016; 02/26/2017; 04/27/2017; 06/29/2017; 08/10/2017 4- Unrelated to Study Device 5 - Recovered Resolved |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment | Start Date(s): 02/23/2017; 12/01/2016; 02/26/2017; 04/27/2017 4 - Unrelated to study device 1 - Recovered / Resolved |
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| Insomnia | Psychiatric disorders | Systematic Assessment | Start Date(s): 08/25/2016; 11/03/2016; 02/16/2017; 10/17/2016; 08/31/2016; 12/01/2016; 04/06/2017; 02/23/2017; 04/13/2017; 06/08/2017; 06/15/2017; 04/27/2017; 08/10/2017 4- Unrelated to the study device 1 - resolved / recovered |
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| Irritability | Psychiatric disorders | Systematic Assessment | Start Date(s): 08/25/2016; 08/23/2017 4 - Unrelated to the study device 1 - Recovered / Resolved |
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| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment | Start Date: 09/22/2016 End Date: Ongoing 4 - Unrelated to the study device 6 - Unknown |
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| Braxton Hicks Contractions | Reproductive system and breast disorders | Systematic Assessment | Start Date: 10/09/2016 End Date: 11/10/2016 4 - Unrelated to the study device 1- Recovered / Resolved |
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| Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Start Date: 10/20/2016; 09/22/2016; 05/04/2017; 02/02/2017 4 - Unrelated to study device 1 - Recovered / Resolved |
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| Carpel Tunnel | Musculoskeletal and connective tissue disorders | Systematic Assessment | Start Date: 10/20/2016 End Date: Ongoing 4 - Unrelated to Study Device 3 - Not recovered / resolved |
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| Anxiety | Psychiatric disorders | Systematic Assessment | Start Date(s): 12/22/2016; 02/09/2017; 03/02/2017; 04/13/2017 4 - Unrelated to study device 3 - not recovered / resolved |
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| Hypervigilance | Psychiatric disorders | Systematic Assessment | Start Date: 01/26/2017 End Date: Ongoing 4 - Unrelated to Study Device 3 - Not recovered / resolved |
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| Drowsiness or sedation | Psychiatric disorders | Systematic Assessment | Start Date: 09/22/2016; 12/12/2016 4 - Unrelated to study device 6 - Unknown |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Start Date: 09/22/2016 End Date: Ongoing 4 - Unrelated to study device 3 - not recovered / resolved |
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| Vaginal Bleeding | Reproductive system and breast disorders | Systematic Assessment | Start Date: 10/27/2016; 02/23/2017 End Date: 10/27/2016; 03/16/2017 4 - Unrelated to study device 1 - recovered / resolved |
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| Bilateral Feet Edema | Blood and lymphatic system disorders | Systematic Assessment | Start Date: 10/24/2016 End Date: 10/27/2016 4 - Unrelated to study device 1 - recovered / resolved |
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| Fatigue | Psychiatric disorders | Systematic Assessment | Start Date(s): 02/16/2017; 10/17/2016 End Date: Ongoing 4 - Unrelated to study device 3 - not resolved / recovered |
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| Postpartum Depression | Psychiatric disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment | Start Date(s): 11/17/2016; 11/16/2016; 06/29/2017 4 - Unrelated to Study Device 1 - Recovered / resolved |
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| Lip Tie | General disorders | Systematic Assessment | Start Date: 05/27/2017 End Date: Ongoing 4 - Unrelated to study device 4 - Residual effects present, not treated |
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| Right Ankle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Start Date: 05/08/2017 End Date: 06/22/2017 4 - Unrelated to study device 1 - recovered / resolved |
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| Allergies | Immune system disorders | Systematic Assessment | Start Date(s): 08/31/2017; 04/27/2017 4 - Unrelated to study device 1 - recovered / resolved |
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| Constipation | Gastrointestinal disorders | Systematic Assessment | Start Date: 10/26/2016; 12/21/2016; 06/29/2017; 04/13/2017 End Date: 11/02/2016; 12/28/2016; 06/29/2017; 05/24/2017 4 - Unrelated to study device 1 - resolved / recovered |
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| Abdominal Cramps | Gastrointestinal disorders | Systematic Assessment | Start Date: 05/23/2017 End Date: 07/17/2017 4 - unrelated to study device 1 - resolved / recovered |
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| Bacterial Vaginosis | Reproductive system and breast disorders | Systematic Assessment | Start Date: 02/05/2017 End Date: 02/16/2017 4 - Unrelated to study device 1 - resolved / recovered |
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| Urinary Tract Infection | Reproductive system and breast disorders | Systematic Assessment | Start Date: 02/10/2017 End Date 03/019/2017 4 - unrelated to study device 1 - resolved / recovered |
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| Yeast Infection | Reproductive system and breast disorders | Systematic Assessment | Start Date: 02/10/2017 End Date: 02/16/2017 4 - unrelated to study device 1 - resolved / recovered |
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| Skin Burning | Injury, poisoning and procedural complications | Systematic Assessment | Start Date: 05/27/2017 End Date: 05/27/2017 4 - unrelated to study device 1 - resolved / recovered |
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| Mastitis | Reproductive system and breast disorders | Systematic Assessment | Start Date: 05/26/2017 End Date: Ongoing 4 - unrelated to study device 3 - not resolved / recovered |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Start Date: 06/29/2017 End Date: Ongoing 4 - unrelated to study device 3 - not resolved / recovered |
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| Hemorrhoid | Gastrointestinal disorders | Systematic Assessment | Start Date: 02/23/2017; 06/29/2017 End Date: Ongoing 4 - unrelated to study device 3 - not resolved / recovered |
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| Sciatica | Nervous system disorders | Systematic Assessment |
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| Tooth pain or Absess | Gastrointestinal disorders | Non-systematic Assessment |
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| Cramping | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Weight Loss | Gastrointestinal disorders | Non-systematic Assessment | Start Date: 06/29/2017 End Date: Ongoing 4 - unrelated to study device 3 - not resolved / recovered |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Start Date: 04/13/2017 End Date: 05/11/2017 4 - unrelated to study device 1 - resolved / recovered |
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| Weight Gain | Gastrointestinal disorders | Non-systematic Assessment | Start Date: 04/27/2017 End Date: Ongoing 4 - unrelated to study device 3 - not resolved / recovered |
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| Hypertension | Cardiac disorders | Non-systematic Assessment |
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| Migraine | Nervous system disorders | Non-systematic Assessment | Start Date: 05/15/2017 End Date: 05/15/2017 4 - unrelated to study device 1 - resolved / recovered |
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| Flank Pain | Renal and urinary disorders | Systematic Assessment |
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| Bilateral Hand Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Numbness/tingling of bilateral hands | Nervous system disorders | Systematic Assessment |
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| Preterm Labor | Reproductive system and breast disorders | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diaper Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Low Lying Kidneys | Renal and urinary disorders | Systematic Assessment |
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| Cellulitis at gastrostomy tube site | Gastrointestinal disorders | Systematic Assessment |
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Early termination due to inability to enroll pregnant subjects into the TMS intervention portion (Part B) of the study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shona Ray-Griffith | University of Arkansas for Medical Sciences | 501-526-8428 | slray@uams.edu |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2021 | Apr 19, 2021 | SAP_003.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|