Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

Spinal Cord Injuries Clinical Trial

Official title:

Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04581525
• Other study ID #: 45535
• Status: Terminated
• Phase: N/A
• Start date: June 7, 2012
• Est. completion date: November 25, 2020

Study information

• Verified date: June 2021
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Neuralgia
• Pain, Neuropathic
• Phantom Limb
• Phantom Limb Pain
• Reflex Sympathetic Dystrophy
• Spinal Cord Injuries

Intervention

Device:
• transcranial direct current stimulation

Locations

Country	Name	City	State
United States	University of Kentucky at Cardinal Hill Rehabilitation Hospital	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Susan McDowell	Foundation for Physical Medicine and Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Short-Form 36 Health Survey from baseline 1 and 2 average	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.	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