Trial Outcomes & Findings for Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain (NCT NCT04578574)
NCT ID: NCT04578574
Last Updated: 2024-03-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
baseline, up to two weeks
Results posted on
2024-03-19
Participant Flow
Participant milestones
| Measure |
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.
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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.
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|---|---|---|
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Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain
Baseline characteristics by cohort
| Measure |
BI-TDCS Stimulation Group
n=6 Participants
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.
|
BI-TDCS (Sham) Stimulation Group
n=2 Participants
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.
|
Total
n=8 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
50 years
STANDARD_DEVIATION 16 • n=99 Participants
|
40 years
STANDARD_DEVIATION 7 • n=107 Participants
|
48 years
STANDARD_DEVIATION 14.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
South America
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, up to two weeksAssessed 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.
Outcome measures
| Measure |
BI-TDCS Stimulation Group
n=6 Participants
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.
|
BI-TDCS (Sham) Stimulation Group
n=2 Participants
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.
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|---|---|---|
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Change in Neuropathic Pain Severity
|
-7.3 score on a scale
Standard Deviation 3.9
|
8.5 score on a scale
Standard Deviation 6.3
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PRIMARY outcome
Timeframe: baseline, up to two weeksAssessed 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.
Outcome measures
| Measure |
BI-TDCS Stimulation Group
n=6 Participants
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.
|
BI-TDCS (Sham) Stimulation Group
n=2 Participants
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.
|
|---|---|---|
|
Change in Performance of Body Part Processing
change scores in mental rotation of body parts
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-18.2 milliseconds (reaction times)
Standard Deviation 67.5
|
30.9 milliseconds (reaction times)
Standard Deviation 25
|
|
Change in Performance of Body Part Processing
change scores in mental rotation of control stimuli
|
-4.5 milliseconds (reaction times)
Standard Deviation 92
|
4.4 milliseconds (reaction times)
Standard Deviation 54
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SECONDARY outcome
Timeframe: baseline, up to two weeksAssessed 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.
Outcome measures
| Measure |
BI-TDCS Stimulation Group
n=6 Participants
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.
|
BI-TDCS (Sham) Stimulation Group
n=2 Participants
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.
|
|---|---|---|
|
Change in Sensory Thresholds
delta pain threshold and perception threshold of painful site expressed as change score (hot-warm)
|
2.2 Celsius
Standard Deviation 6.5
|
-1.3 Celsius
Standard Deviation 4
|
|
Change in Sensory Thresholds
delta pain thresh. and perception threshold of painful site expressed as change score (cold-cool)
|
-1.37 Celsius
Standard Deviation 5.4
|
3.9 Celsius
Standard Deviation 1
|
Adverse Events
BI-TDCS Stimulation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI-TDCS (Sham) Stimulation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eva Widerstrom-Noga, PhD; Roberta Vastano, PhD
University of Miami
Phone: 305243-7125; 305243-8847
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place