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Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

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ClinicalTrials.gov Identifier: NCT04581525
Recruitment Status : Terminated (Insufficient staff to carry out study)
First Posted : October 9, 2020
Last Update Posted : June 14, 2021
Sponsor:
Collaborator:
Foundation for Physical Medicine and Rehabilitation
Information provided by (Responsible Party):
Susan McDowell, University of Kentucky

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 7, 2012
Actual Primary Completion Date : November 25, 2020
Actual Study Completion Date : November 25, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in McGill Pain Questionnaire from baseline 1 and 2 average [ Time Frame: 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 :
  1. Change in Short-Form 36 Health Survey from baseline 1 and 2 average [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581525


Locations
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United States, Kentucky
University of Kentucky at Cardinal Hill Rehabilitation Hospital
Lexington, Kentucky, United States, 40504
Sponsors and Collaborators
Susan McDowell
Foundation for Physical Medicine and Rehabilitation
Investigators
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Principal Investigator: Susan McDowell, MD University of Kentucky
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Responsible Party: Susan McDowell, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04581525    
Other Study ID Numbers: 45535
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan McDowell, University of Kentucky:
neuroplasticity
rehabilitation
transcranial direct current stimulation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Neuralgia
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Phantom Limb
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Autonomic Nervous System Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Pain, Postoperative
Postoperative Complications
Pathologic Processes