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| ID | Type | Description | Link |
|---|---|---|---|
| I21RX RX002032 | Other Grant/Funding Number | VA |
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The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD. Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome measures focusing on changes in PTSD symptom severity and quality of life and social/occupation functioning.
The purpose of the proposed study is to evaluate the feasibility of theta burst transcranial magnetic stimulation (TBS) as an adjunct treatment for Veterans with PTSD. This project will result in development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD, which will assess the relationship between change in symptoms and quality of life. It will also lay the foundation for subsequent rehabilitation studies combining neuromodulation and psychotherapy in the longer term.
TBS has several advantages compared to standard repetitive Transcranial Magnetic Stimulation (rTMS), including its ability to deliver large numbers of stimulation pulses in a shorter time period, and a stimulation pattern that may specifically affect key brain regions involved in PTSD. The significance of this research is the development of a novel, non-invasive brain stimulation approach for PTSD recovery. This project will provide the foundation for the development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD to ultimately develop brain stimulation techniques that can be combined with evidence-based psychotherapy, to develop a more powerful, individualized rehabilitation option for Veterans with PTSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Stimulation | Sham Comparator | A sham coil is being used to compare against active coil. |
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| Active Stimulation | Active Comparator | An active coil is being used to compare against sham coil. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theta burst stimulation | Device | Theta burst transcranial magnetic stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Retained, a Measure of Acceptability of TBS Procedures | Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Due to TBS Treatment | Change in the quality of life, using the quality of life questionnaire QLESQ - Quality of Life Enjoyment and Satisfaction Questionnaire (General Quality of Life Index). A self-report scale covering multiple domains (physical health, subjective feelings, leisure time activities, social relationships, treatment satisfaction) The General Quality of Life Index took the mean of all domains. Scores range from 0-5, with higher scores indicating higher quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
Cardiac pacemaker
implanted device (deep brain stimulation) or metal in the brain
cervical spinal cord
or upper thoracic spinal cord
pregnancy/lactation, or planning to become pregnant during the study
lifetime history of moderate or severe traumatic brain injury (TBI)
current unstable medical conditions
current (or past if appropriate) significant neurological disorder, or lifetime history of:
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| Name | Affiliation | Role |
|---|---|---|
| Noah S. Philip, MD | Providence VA Medical Center, Providence, RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence VA Medical Center, Providence, RI | Providence | Rhode Island | 02908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31230462 | Derived | Philip NS, Barredo J, Aiken E, Larson V, Jones RN, Shea MT, Greenberg BD, van 't Wout-Frank M. Theta-Burst Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder. Am J Psychiatry. 2019 Nov 1;176(11):939-948. doi: 10.1176/appi.ajp.2019.18101160. Epub 2019 Jun 24. |
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6 participants were excluded during pre-assignment.
Participants consented at a formal in-person eligibility determination (screening).
Location: Providence, RI
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Stimulation | Participants allocated to receive sham TBS during the double-blind period |
| FG001 | Active Stimulation | Participants allocated to receive active TBS during the double-blind period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-Blind (0-2 Weeks) |
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| Unblinded (Optional 2-4 Weeks) |
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| Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Stimulation | Participants allocated to receive sham TBS during the double-blind period |
| BG001 | Active Stimulation | Participants allocated to receive active TBS during the double-blind period. |
| 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 |
| 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 | Number of Participants Retained, a Measure of Acceptability of TBS Procedures | Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation) | Data was analyzed in an intent-to-treat fashion, defined as participants that were randomized and received at least one iTBS session. | Posted | Count of Participants | Participants | 2 weeks |
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Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
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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 | Pre-Allocation | Participants consented at formal in-person eligibility determination. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient hospitalization | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Treatment site discomfort | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Noah S. Philip | Providence VA Medical Center, Center for Neurorestoration and Neurotechnology | 401-273-7100 | 6235 | noah.philip@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2017 | Feb 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Sham stimulation |
| Device |
Sham Theta burst transcranial magnetic stimulation |
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| Baseline and end of double-blind period (2 weeks) |
| Change in PTSD Symptom Severity | Change in PTSD symptoms measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 is a structured interview to measure for PTSD symptom change and presence/absence of PTSD, items rated 0 = 'absent' to 4 = 'extreme/incapacitating,' total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Higher scores indicate more severe PTSD symptoms. | Baseline and end of double-blind period (2 weeks) |
| Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment | Change measured using the social/occupational functioning assessment scale (SOFAS). Clinician rating of social & occupational functioning. Scale of 0-100 with higher scores indicating higher functioning. | Baseline and end of double-blind period (2 weeks) |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | 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 | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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| Military History | Military Branch corresponding with participant's report of service branch at time of discharge. | Count of Participants | Participants |
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| Psychiatric Comorbidity | Count of Participants | Participants |
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| Prior Brain Stimulation | Count of Participants | Participants |
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| Mild Traumatic Brain Injury | Count of Participants | Participants |
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| Psychiatric History | Count of Participants | Participants |
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| PTSD Symptom Severity | CAPS-5, Clinician Administered PTSD Scale for DSM-5: structured interview to assess PTSD symptoms over the past month, items rated 0 = 'absent' to 4 = 'extreme/incapacitating,' total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. PCL-5, PTSD Checklist for DSM-5: a 20-item self-report measure where participants are asked to respond about experience(s) "over past month,", items are rated 0 = "not at all bothered by" to 4 = "extremely bothered," total symptom severity score ranges 0-80, higher scores indicate more severe PTSD symptoms. | Mean | Standard Deviation | score on a scale |
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| Social/Occupational Function & Quality of Life | SOFAS, Social and Occupational Function Scale: Clinician rating of social & occupational functioning. Scale of 0-100 with higher scores indicating higher functioning. QLESQ (General Quality of Life Index), Quality of Life Enjoyment and Satisfaction: A self-report scale covering multiple domains (physical health, subjective feelings, leisure time activities, social relationships, treatment) The General Quality of Life Index took the mean of all domains. Scores range from 0-5, with higher scores indicating higher quality of life. | Mean | Standard Deviation | score on a scale |
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| Depressive Symptom Severity | IDSSR Score, Inventory of Depressive Symptomatology, Self-Report: participant self report of depressive symptoms over the past week based on 30 items (28 are scored), items rated 0-3. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being severe depressive symptoms. | Mean | Standard Deviation | score on a scale |
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| Secondary | Change in Quality of Life Due to TBS Treatment | Change in the quality of life, using the quality of life questionnaire QLESQ - Quality of Life Enjoyment and Satisfaction Questionnaire (General Quality of Life Index). A self-report scale covering multiple domains (physical health, subjective feelings, leisure time activities, social relationships, treatment satisfaction) The General Quality of Life Index took the mean of all domains. Scores range from 0-5, with higher scores indicating higher quality of life. | Data was analyzed in an intent-to-treat fashion. Primary outcomes were measured using analysis of variance to compare groups at the end of the 2-week double blind phase. Missing data was addressed using multiple imputation, with 20 imputations or maximum likelihood parameter estimation in mixed model analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline and end of double-blind period (2 weeks) |
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| Secondary | Change in PTSD Symptom Severity | Change in PTSD symptoms measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 is a structured interview to measure for PTSD symptom change and presence/absence of PTSD, items rated 0 = 'absent' to 4 = 'extreme/incapacitating,' total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Higher scores indicate more severe PTSD symptoms. | Included all subjects who were randomized. Primary outcomes were measured using analysis of variance to compare groups at the end of the 2-week double blind phase. Missing data was addressed using multiple imputation, with 20 imputations or maximum likelihood parameter estimation in mixed model analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline and end of double-blind period (2 weeks) |
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| Secondary | Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment | Change measured using the social/occupational functioning assessment scale (SOFAS). Clinician rating of social & occupational functioning. Scale of 0-100 with higher scores indicating higher functioning. | Included all subjects who were randomized. Primary outcomes were measured using analysis of variance to compare groups at the end of the 2-week double blind phase. Missing data was addressed using multiple imputation, with 20 imputations or maximum likelihood parameter estimation in mixed model analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline and end of double-blind period (2 weeks) |
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| 0 |
| 56 |
| 1 |
| 56 |
| 0 |
| 56 |
| EG001 | Sham Stimulation | Participants allocated to receive sham TBS during the double-blind period | 0 | 25 | 2 | 25 | 2 | 25 |
| EG002 | Active Stimulation | Participants allocated to receive active TBS during the double-blind period. | 0 | 25 | 0 | 25 | 9 | 25 |
| Homicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| Headache | Psychiatric disorders | Non-systematic Assessment |
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