Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

NCT ID: NCT04581525

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-07
• Study Completion Date: 2020-11-25

Brief Summary

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

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.

Conditions

Pain, Neuropathic; Complex Regional Pain Syndromes; Phantom Limb Pain; Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

Sham tDCS

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

Group Type: SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

Interventions

transcranial direct current stimulation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Physical Medicine and Rehabilitation

OTHER

Sponsor Role: collaborator

Susan McDowell

OTHER

Sponsor Role: lead

Responsible Party

Susan McDowell

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Susan McDowell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

45535

Identifier Type: -

Identifier Source: org_study_id