Clinical trial NCT04581525: Modulating Neuropathic Pain With Transcranial Direct Current Stimulation
Official title: Modulating Neuropathic Pain With Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Neuropathic
Complex Regional Pain Syndromes
Phantom Limb Pain
Spinal Cord Injuries
Keywords: neuroplasticity
rehabilitation
transcranial direct current stimulation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Medicine and Rehabilitation
First posted: 2020-10-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in McGill Pain Questionnaire from baseline 1 and 2 average
timeFrame: 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:
measure: Change in Short-Form 36 Health Survey from baseline 1 and 2 average
timeFrame: 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
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky at Cardinal Hill Rehabilitation Hospital
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Susan McDowell, MD
role: PRINCIPAL_INVESTIGATOR
References: