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Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

Primary Purpose

Pain, Neuropathic, Complex Regional Pain Syndromes, Phantom Limb Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Susan McDowell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Neuropathic focused on measuring neuroplasticity, rehabilitation, transcranial direct current stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky at Cardinal Hill Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

tDCS of DLPFC

tDCS of M1

Sham tDCS

Arm Description

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.

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.

Subjects will receive 20 minutes of sham transcranial direct current stimulation. Subjects will undergo stimulation once a day for 10 consecutive weekdays.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 28, 2020
Last Updated
June 9, 2021
Sponsor
Susan McDowell
Collaborators
Foundation for Physical Medicine and Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT04581525
Brief Title
Modulating Neuropathic Pain With Transcranial Direct Current Stimulation
Official Title
Modulating Neuropathic Pain With Transcranial Direct Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Insufficient staff to carry out study
Study Start Date
June 7, 2012 (Actual)
Primary Completion Date
November 25, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susan McDowell
Collaborators
Foundation for Physical Medicine and Rehabilitation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuropathic, Complex Regional Pain Syndromes, Phantom Limb Pain, Spinal Cord Injuries
Keywords
neuroplasticity, rehabilitation, transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS of DLPFC
Arm Type
Experimental
Arm Description
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.
Arm Title
tDCS of M1
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Subjects will receive 20 minutes of sham transcranial direct current stimulation. Subjects will undergo stimulation once a day for 10 consecutive weekdays.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Change in McGill Pain Questionnaire from baseline 1 and 2 average
Description
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.
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
Secondary Outcome Measure Information:
Title
Change in Short-Form 36 Health Survey from baseline 1 and 2 average
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan McDowell, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky at Cardinal Hill Rehabilitation Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

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