Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

NCT04581525 | Terminated

• 1 other identifier: 45535
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

neuroplasticity; rehabilitation; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Change in McGill Pain Questionnaire from baseline 1 and 2 average

  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.

  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

Secondary Outcomes (1)

• 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

Study Arms (3)

tDCS of DLPFC

EXPERIMENTAL

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

tDCS of M1

EXPERIMENTAL

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 tDCS

SHAM COMPARATOR

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

Interventions

transcranial direct current stimulation DEVICE

Sham tDCS; tDCS of DLPFC; tDCS of M1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Susan McDowell: lead
• Foundation for Physical Medicine and Rehabilitation: collaborator

Study Sites (1)

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Neuralgia; Complex Regional Pain Syndromes; Phantom Limb; Spinal Cord Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Susan McDowell, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 9, 2020
• Study Start: June 7, 2012
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)