Neuropathic Pain
Conditions
Brief summary
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.
Interventions
OTHERBodily 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.
DEVICETranscranial 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.
OTHERSham Transcranial Direct Electrical Stimulation (tDCS)
Each session of the Sham tDCS will be applied for 30 min at the same time as the BI.
Sponsors
Florida
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Participants will be men or women, 18-70 years of age, with an incomplete cervical traumatic SCI. 2. Participants must have experienced neuropathic pain for a minimum of six months. They must have neuropathic pain in the moderate to severe category, which will be defined as a score of at least 4 on a Numeric Rating Scale (NRS); (range of 0 to 10). 3. Participants must be willing and able to sign informed consent
Exclusion criteria
1. Major psychiatric disease/disorder (self-reported) 2. A significant neurological trauma besides SCI 3. A recent (one-year) history of alcohol or drug abuse (selfreported) 4. Any other medical conditions in which transcranial DCS is relatively contraindicated, such as pregnancy, epilepsy and/or seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neuropathic Pain Severity | baseline, up to two weeks | 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. |
| Change in Performance of Body Part Processing | baseline, up to two weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sensory Thresholds | baseline, up to two weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 2 |
| Total | 8 |
Baseline characteristics
| Characteristic | BI-TDCS Stimulation Group | BI-TDCS (Sham) Stimulation Group | Total |
|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 16 | 40 years STANDARD_DEVIATION 7 | 48 years STANDARD_DEVIATION 14.9 |
| Race/Ethnicity, Customized Black American | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 0 Participants | 3 Participants |
| Region of Enrollment South America | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 5 participants | 2 participants | 7 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 2 |
| other Total, other adverse events | 0 / 6 | 0 / 2 |
| serious Total, serious adverse events | 0 / 6 | 0 / 2 |
Outcome results
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.
Time frame: baseline, up to two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BI-TDCS Stimulation Group | Change in Neuropathic Pain Severity | -7.3 score on a scale | Standard Deviation 3.9 |
| BI-TDCS (Sham) Stimulation Group | Change in Neuropathic Pain Severity | 8.5 score on a scale | Standard Deviation 6.3 |
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.
Time frame: baseline, up to two weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BI-TDCS Stimulation Group | Change in Performance of Body Part Processing | change scores in mental rotation of body parts | -18.2 milliseconds (reaction times) | Standard Deviation 67.5 |
| BI-TDCS Stimulation Group | Change in Performance of Body Part Processing | change scores in mental rotation of control stimuli | -4.5 milliseconds (reaction times) | Standard Deviation 92 |
| BI-TDCS (Sham) Stimulation Group | Change in Performance of Body Part Processing | change scores in mental rotation of body parts | 30.9 milliseconds (reaction times) | Standard Deviation 25 |
| BI-TDCS (Sham) Stimulation Group | Change in Performance of Body Part Processing | change scores in mental rotation of control stimuli | 4.4 milliseconds (reaction times) | Standard Deviation 54 |
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.
Time frame: baseline, up to two weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BI-TDCS Stimulation Group | 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 |
| BI-TDCS Stimulation Group | 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 |
| BI-TDCS (Sham) Stimulation Group | Change in Sensory Thresholds | delta pain threshold and perception threshold of painful site expressed as change score (hot-warm) | -1.3 Celsius | Standard Deviation 4 |
| BI-TDCS (Sham) Stimulation Group | Change in Sensory Thresholds | delta pain thresh. and perception threshold of painful site expressed as change score (cold-cool) | 3.9 Celsius | Standard Deviation 1 |