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This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS) to relieve pain in cancer patients who developed neuropathic pain in the affected area after a surgical intervention, radiation therapy, or chemotherapy to treat the disease.
This is a pilot study that aims to determine the effect of repetitive tDCS stimulation, performed on five consecutive days at intensity of 2 mA, on pain and somatosensory abnormalities in patients with neuropathic pain that followed surgical, radiation or chemotherapeutic treatment, and to evaluate safety of tDCS in the same model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| real tDCS stimulation | Experimental | non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days. |
|
| Sham tDCS | Sham Comparator | sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive transcranial direct current stimulation (tDCS) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure "Pain intensity" assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2). | Assessed at baseline and post tDCS stimulation day 5 |
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Adult male and female patients with cancer who developed neuropathic pain in the affected area secondary the surgical procedure, chemotherapy or radiation that meet the following Inclusion/Exclusion criteria:
Inclusion Criteria:
Pain on the side of the lesion
Spontaneous pain with a score for "worst pain in the last 24 hours" >4 on a numeric scale 0-10
Must present the following symptoms and signs:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena Knotkova, PhD | Beth Israel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Isael Medical Center | New York, USA | New York | 10003 | United States |
38 subjects consented; 8 screen failures; 6 never started; 24 were randomized. 1 subject withdrew after undergoing 4 of 5 tDCS/sham sessions. 23 completed randomized study.
191 subjects identified. 33 were ineligible at pre-screening; 40 not reacahble; 21 lost to follow-up; 3 deceased; 56 not interested. 38 subjects consented.
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| ID | Title | Description |
|---|---|---|
| FG000 | Real tDCS Stimulation | non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days. |
| FG001 | Sham tDCS | sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Real tDCS Stimulation | non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days. |
| BG001 | Sham tDCS |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Pain Intensity | Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure "Pain intensity" assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2). | Posted | Mean | Standard Error | Points on numerical rating scale | Assessed at baseline and post tDCS stimulation day 5 |
|
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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 | Real tDCS Stimulation | non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of shortness of breath | Respiratory, thoracic and mediastinal disorders | Exacerbation of shortness of breath and chest pain on 2 occasions in the follow-up period. Symptoms were attributed to opioid medication regimen and patient's anxiety, and the issue was resolved. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helena Knotkova, PhD | Beth Israel Medical Center | 212-844-8541 | hknotkov@chpnet.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sham tDCS | sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days. |
|
|
| 1 |
| 16 |
| 10 |
| 16 |
| EG001 | Sham tDCS | sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days. | 1 | 8 | 5 | 8 |
|
| Exacerbation of Pain due to rectal cellulitis | Gastrointestinal disorders |
|
| Transient change in mental status | Psychiatric disorders |
|
| Fatigue | General disorders |
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| Transient Pain | General disorders |
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| Interrupted Sleep | General disorders |
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| Hypotension | General disorders |
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| Dizziness | General disorders |
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| Dry Mouth | General disorders |
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| Numbness | General disorders |
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| Worsening of Pain | General disorders |
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| Tongue tingling | General disorders | Subject with diagnosis of cancer of the base of tongue; tongue tingling developed as a part of cancer treatment prior to study participation |
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| Cellulitis | Skin and subcutaneous tissue disorders |
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| Memory lapse | Nervous system disorders | transient increase of memory lapse in elderly subject with history of CVA affecting frontal lobe. |
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| Clear discharge from ear | Ear and labyrinth disorders |
|
| Urinary tract infection | Renal and urinary disorders |
|
| Flu-like symptoms | Respiratory, thoracic and mediastinal disorders |
|
| Tibial fracture | Musculoskeletal and connective tissue disorders | tibial fracture due to mechanical fall |
|
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