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| Name | Class |
|---|---|
| Florida | OTHER |
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The purpose of this study is to evaluate the effect of a combination of two procedures: (1) Bodily Illusion (BI) and (2) Transcranial direct electrical stimulation (tDCS) on neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI-TDCS Stimulation Group | Experimental | Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks. |
|
| BI-TDCS (Sham) Stimulation Group | Sham Comparator | Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bodily Illusions (BI) Procedure | Other | Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neuropathic Pain Severity | Assessed by the use of the Neuropathic Pain Symptom Inventory (NPSI). The NPSI has a total score ranging from 0 to 100 with the higher score indicating greater pain. | baseline, up to two weeks |
| Change in Performance of Body Part Processing | Assessed by a customized computer task, where individual reaction times will be measured in response to mental rotation of body parts. Results will be reported in milliseconds. | baseline, up to two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sensory Thresholds | Assessed by the Quantitative Sensory Testing. Pain thresholds are evaluated using Medoc machine (Medoc Ltd,Ramat Yishai, Israel and FDA approved. It assesses participants' ability to feel change in temperature (0°C to 50°C). The temperatures in this range may be felt as cool, cold, warm, and hot. A probe is placed on the skin and it feels either cool, cold, warm or hot. Participants' thresholds are recorded for cool or warm sensation, and for cold or hot painful thresholds. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Widerstrom-Noga, Phd | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | BI Transcranial Direct Current Stimulation (TDCS) Stimulation Group | Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks. Bodily Illusions (BI) Procedure: Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs. Transcranial direct electrical stimulation (tDCS): Each sessions will consists of electrical current delivered from a battery-driven, constant current stimulator using saline-soaked surface sponge electrodes. One electrode will be placed on your scalp on the right side and the other electrode over the left eye on your forehead. A weak current will be applied for 30 min at the same time as the BI. |
| FG001 | BI-TDCS (Sham) Stimulation Group | Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks. Bodily Illusions (BI) Procedure: Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs. Sham Transcranial Direct Electrical Stimulation (tDCS): Each session of the Sham tDCS will be applied for 30 min at the same time as the BI. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BI-TDCS Stimulation Group | Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks. Bodily Illusions (BI) Procedure: Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs. Transcranial direct electrical stimulation (tDCS): Each sessions will consists of electrical current delivered from a battery-driven, constant current stimulator using saline-soaked surface sponge electrodes. One electrode will be placed on your scalp on the right side and the other electrode over the left eye on your forehead. A weak current will be applied for 30 min at the same time as the BI. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 in Neuropathic Pain Severity | Assessed by the use of the Neuropathic Pain Symptom Inventory (NPSI). The NPSI has a total score ranging from 0 to 100 with the higher score indicating greater pain. | Posted | Mean | Standard Deviation | score on a scale | baseline, up to two weeks |
|
1 year (during data collection)
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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 | BI-TDCS Stimulation Group | Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks. Bodily Illusions (BI) Procedure: Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs. Transcranial direct electrical stimulation (tDCS): Each sessions will consists of electrical current delivered from a battery-driven, constant current stimulator using saline-soaked surface sponge electrodes. One electrode will be placed on your scalp on the right side and the other electrode over the left eye on your forehead. A weak current will be applied for 30 min at the same time as the BI. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Widerstrom-Noga, PhD; Roberta Vastano, PhD | University of Miami | 305243-7125; 305243-8847 | ewiderstrom-noga@med.miami.edu; Rxv331@med.miami.edu |
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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 | Feb 21, 2024 | Feb 21, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Transcranial direct electrical stimulation (tDCS) | Device | Each sessions will consists of electrical current delivered from a battery-driven, constant current stimulator using saline-soaked surface sponge electrodes. One electrode will be placed on your scalp on the right side and the other electrode over the left eye on your forehead. A weak current will be applied for 30 min at the same time as the BI. |
|
| Sham Transcranial Direct Electrical Stimulation (tDCS) | Other | Each session of the Sham tDCS will be applied for 30 min at the same time as the BI. |
|
| baseline, up to two weeks |
| BG001 | BI-TDCS (Sham) Stimulation Group | Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks. Bodily Illusions (BI) Procedure: Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs. Sham Transcranial Direct Electrical Stimulation (tDCS): Each session of the Sham tDCS will be applied for 30 min at the same time as the BI. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | BI-TDCS (Sham) Stimulation Group | Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks. Bodily Illusions (BI) Procedure: Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs. Sham Transcranial Direct Electrical Stimulation (tDCS): Each session of the Sham tDCS will be applied for 30 min at the same time as the BI. |
|
|
| Primary | Change in Performance of Body Part Processing | Assessed by a customized computer task, where individual reaction times will be measured in response to mental rotation of body parts. Results will be reported in milliseconds. | Posted | Mean | Standard Deviation | milliseconds (reaction times) | baseline, up to two weeks |
|
|
|
| Secondary | Change in Sensory Thresholds | Assessed by the Quantitative Sensory Testing. Pain thresholds are evaluated using Medoc machine (Medoc Ltd,Ramat Yishai, Israel and FDA approved. It assesses participants' ability to feel change in temperature (0°C to 50°C). The temperatures in this range may be felt as cool, cold, warm, and hot. A probe is placed on the skin and it feels either cool, cold, warm or hot. Participants' thresholds are recorded for cool or warm sensation, and for cold or hot painful thresholds. | Posted | Mean | Standard Deviation | Celsius | baseline, up to two weeks |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | BI-TDCS (Sham) Stimulation Group | Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks. Bodily Illusions (BI) Procedure: Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs. Sham Transcranial Direct Electrical Stimulation (tDCS): Each session of the Sham tDCS will be applied for 30 min at the same time as the BI. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |