Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

June 9, 2021 updated by: Susan McDowell
This study will examine whether a form of non-invasive brain stimulation can help reduce pain in people with persistent neuropathic pain.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • University of Kentucky at Cardinal Hill Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Susan McDowell

Collaborators

Foundation for Physical Medicine and Rehabilitation

Investigators

  • Principal Investigator: Susan McDowell, MD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 7, 2012

Primary Completion (ACTUAL)

November 25, 2020

Study Completion (ACTUAL)

November 25, 2020

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (ACTUAL)

October 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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