Trial Outcomes & Findings for Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees (NCT NCT02627495)

Last Updated: 2021-05-11

Results Overview

The VAS is a common assessment used which asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). We will use a VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain.

Recruitment status

COMPLETED

Target enrollment

9 participants

Primary outcome timeframe

Change in outcome from baseline to 2-week follow-up (after the last day of stimulation)

Results posted on

2021-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	tDCS Intervention (Open Label) Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm\^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.
Overall Study STARTED	9
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	tDCS Intervention (Open Label) Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm\^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	tDCS Intervention (Open Label) n=9 Participants Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm\^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Age, Continuous	54.6 years STANDARD_DEVIATION 16.58 • n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	9 Participants n=93 Participants

PRIMARY outcome

Timeframe: Change in outcome from baseline to 2-week follow-up (after the last day of stimulation)

Outcome measures

Outcome measures
Measure	tDCS Intervention (Open Label) n=9 Participants Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm\^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.
Pain as Measured by the Visual Analog Scale	-1.4 units on a scale Standard Deviation 1.14

Adverse Events

tDCS Intervention (Open Label)

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

Prof. Felipe Fregni

Spaulding Rehabilitation Hospital

Phone: +1 (617) 935-2743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place