An interventional study of Bodily Illusions (BI) Procedure and Transcranial direct electrical stimulation (tDCS) in Neuropathic Pain, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by University of Miami · Not applicable, Interventional, and Basic science
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.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 8 is below the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks.
Other: Bodily Illusions (BI) Procedure · Device: Transcranial direct electrical stimulation (tDCS)
Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks.
Other: Bodily Illusions (BI) Procedure · Other: Sham Transcranial Direct Electrical Stimulation (tDCS)
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.
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.
Each session of the Sham tDCS will be applied for 30 min at the same time as the BI.
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.
Time frame: 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.
Time frame: baseline, up to two weeks
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.
Time frame: baseline, up to two weeks
| Milestone | BI Transcranial Direct Current Stimulation (TDCS) Stimulation Group | BI-TDCS (Sham) Stimulation Group |
|---|---|---|
| Started | 6 | 2 |
| Completed | 6 | 2 |
| Not completed | 0 | 0 |
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.
| score on a scale | BI-TDCS Stimulation Group | BI-TDCS (Sham) Stimulation Group |
|---|---|---|
| Change in Neuropathic Pain Severity | -7.3 ± 3.9 | 8.5 ± 6.3 |
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.
| milliseconds (reaction times) | BI-TDCS Stimulation Group | BI-TDCS (Sham) Stimulation Group |
|---|---|---|
| change scores in mental rotation of body parts | -18.2 ± 67.5 | 30.9 ± 25 |
| change scores in mental rotation of control stimuli | -4.5 ± 92 | 4.4 ± 54 |
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.
| Celsius | BI-TDCS Stimulation Group | BI-TDCS (Sham) Stimulation Group |
|---|---|---|
| delta pain threshold and perception threshold of painful site expressed as change score (hot-warm) | 2.2 ± 6.5 | -1.3 ± 4 |
| delta pain thresh. and perception threshold of painful site expressed as change score (cold-cool) | -1.37 ± 5.4 | 3.9 ± 1 |
Collected over 1 year (during data collection). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BI-TDCS Stimulation Group | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| BI-TDCS (Sham) Stimulation Group | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | BI-TDCS Stimulation Group | BI-TDCS (Sham) Stimulation Group | Total |
|---|---|---|---|
| Mean | 50 ± 16 | 40 ± 7 | 48 ± 14.9 |
| Sex: Female, Male(Participants) | BI-TDCS Stimulation Group | BI-TDCS (Sham) Stimulation Group | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 4 | 2 | 6 |
| Race/Ethnicity, Customized(Participants) | BI-TDCS Stimulation Group | BI-TDCS (Sham) Stimulation Group | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| White | 3 | 0 | 3 |
| Black American | 0 | 2 | 2 |
| Region of Enrollment(participants) | BI-TDCS Stimulation Group | BI-TDCS (Sham) Stimulation Group | Total |
|---|---|---|---|
| United States | 5 | 2 | 7 |
| South America | 1 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Miami