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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

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

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

NCT ID

NCT04581525

First Posted

September 28, 2020

Last Updated

June 9, 2021

Sponsor

Susan McDowell

Collaborators

Foundation for Physical Medicine and Rehabilitation

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Arm Title

tDCS of M1

Arm Type

Experimental

Arm Description

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

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Learn more about this trial

Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

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