Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

Sponsor

Susan McDowell (Other)

Overall Status

Terminated

CT.gov ID

NCT04581525

Collaborator

Foundation for Physical Medicine and Rehabilitation (Other)

Enrollment

Location

Arms

101.6

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine whether a form of non-invasive brain stimulation can help reduce pain in people with persistent neuropathic pain.

Condition or Disease	Intervention/Treatment	Phase
Pain, Neuropathic Complex Regional Pain Syndromes Phantom Limb Pain Spinal Cord Injuries	Device: transcranial direct current stimulation	N/A

Detailed Description

This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of three groups by chance. Two groups will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

Actual Study Start Date :

Jun 7, 2012

Actual Primary Completion Date :

Nov 25, 2020

Actual Study Completion Date :

Nov 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tDCS of DLPFC Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left dorsolateral prefrontal cortex (DLPFC). Subjects will undergo stimulation once a day for 10 consecutive weekdays.	Device: transcranial direct current stimulation
Experimental: tDCS of M1 Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left primary motor cortex (M1). Subjects will undergo stimulation once a day for 10 consecutive weekdays.	Device: transcranial direct current stimulation
Sham Comparator: Sham tDCS Subjects will receive 20 minutes of sham transcranial direct current stimulation. Subjects will undergo stimulation once a day for 10 consecutive weekdays.	Device: transcranial direct current stimulation

Arm

Intervention/Treatment

Experimental: tDCS of DLPFC

Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left dorsolateral prefrontal cortex (DLPFC). Subjects will undergo stimulation once a day for 10 consecutive weekdays.

Device: transcranial direct current stimulation

Experimental: tDCS of M1

Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left primary motor cortex (M1). Subjects will undergo stimulation once a day for 10 consecutive weekdays.

Device: transcranial direct current stimulation

Sham Comparator: Sham tDCS

Subjects will receive 20 minutes of sham transcranial direct current stimulation. Subjects will undergo stimulation once a day for 10 consecutive weekdays.

Device: transcranial direct current stimulation

Outcome Measures

Primary Outcome Measures

Change in McGill Pain Questionnaire from baseline 1 and 2 average [Baseline 1: 1 week before starting intervention, Baseline 2: immediately before starting intervention, Intervention mid-point: after 5 days intervention, Post-intervention: after 10 days intervention, Follow up: 1 month after completing intervention]
This self-reported assessment measures intensity and quality of pain. Scores can range from 0 to 45. A decrease in score indicates an improvement in pain.

Secondary Outcome Measures

Change in Short-Form 36 Health Survey from baseline 1 and 2 average [Baseline 1: 1 week before starting intervention, Baseline 2: immediately before starting intervention, Intervention mid-point: after 5 days intervention, Post-intervention: after 10 days intervention, Follow up: 1 month after completing intervention]
This self-reported assessment provides information regarding an individual's perception of their health and quality of life. Scores range from 0 to 100. An increase in score indicates an improvement in perceived health and quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

At least 18 years of age
Have chronic (>12 months) neuropathic pain, including but not limited to complex regional pain syndrome, phantom limb pain, or pain of neurogenic origin following spinal cord injury

Exclusion Criteria:

History of seizures or epilepsy
Addition or change in the dosage of drugs now to interfere with pain within 1 month of enrollment
Untreated depression
History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
Positive pregnancy test or being of childbearing age and not using appropriate contraception
Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain