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Spaulding-Harvard Model System: Effects of Transcranial Direct Current Stimulation (tDCS) on Chronic Pain in Spinal Cord Injury

Primary Purpose

Spinal Cord Injury, Chronic Pain, Neuropathic Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial direct current stimulation (tDCS)

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring transcranial stimulation, direct current

Eligibility Criteria

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

Inclusion Criteria:

Over 18 years of age
History of moderate to severe sublesional pain

Exclusion Criteria:

Active alcohol or drug dependence, as self-reported
A history of bipolar disorder or psychosis, as self-reported
Inability to travel to the study site,
Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment [53]: carbamazepine, oxcarbazepine, phenytoin, ropinirole (Requip), pramipexole (Mirapex), and cabergoline (Dostinex),
The following contradictions to tDCS: implanted metal plates in the head, or deep brain stimulator (spinal cord implants, including baclofen pumps, are not a contraindication as cranial currents do not reach the spinal cord [24]).
Pregnancy at time of enrollment
Current use of ventilator.

Sites / Locations

Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Subjects will undergo 20 minutes active tDCS.

Subjects will undergo 20 minutes of sham stimulation.

Outcomes

Primary Outcome Measures

Change in Pain Scale

Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with chronic sublesional neuropathic pain due to spinal cord injury, as measured by changes in the Brief Pain Inventory (BPI) from baseline to follow-up (up to 2 months after the final stimulation session).

Secondary Outcome Measures

Changes in Quality of Life Scale

Determine whether anodal transcranial direct current stimulation is effective in increasing quality of life in subjects with chronic neuropathic sublesional pain due to spinal cord injury, as measured by changes in the Satisfaction with Life Scale (SWLS), from baseline to follow-up (up to 2 months after the final stimulation session).

Changes in Mood Scale

Determine whether anodal transcranial direct current stimulation is effective in improving mood in subjects with chronic neuropathic sublesional pain due to spinal cord injury, as measured by changes in the Patient Health Questionnaire-9 (PHQ9), from baseline to follow-up (up to 2 months after the final stimulation session).

Full Information

NCT ID

NCT01599767

First Posted

February 8, 2012

Last Updated

April 23, 2020

Sponsor

Spaulding Rehabilitation Hospital

Collaborators

U.S. Department of Education

1. Study Identification

Unique Protocol Identification Number

NCT01599767

Brief Title

Spaulding-Harvard Model System: Effects of Transcranial Direct Current Stimulation (tDCS) on Chronic Pain in Spinal Cord Injury

Official Title

Spaulding-Harvard Spinal Cord Injury (SH-SCI) Study: Effects of tDCS on Chronic Pain in Spinal Cord Injury.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Spaulding Rehabilitation Hospital

Collaborators

U.S. Department of Education

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

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with spinal cord injury. This study is part of the Spaulding-Harvard Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 1 week of stimulation (5 consecutive days) followed by 2 weeks of stimulation (10 consecutive days) after a 3-month follow up visit. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation. If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury, Chronic Pain, Neuropathic Pain

Keywords

transcranial stimulation, direct current

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS

Arm Type

Experimental

Arm Description

Subjects will undergo 20 minutes active tDCS.

Arm Title

Sham tDCS

Arm Type

Sham Comparator

Arm Description

Subjects will undergo 20 minutes of sham stimulation.

Intervention Type

Device

Intervention Name(s)

Transcranial direct current stimulation (tDCS)

Other Intervention Name(s)

1x1 low-intensity direct current stimulator, Soterix Medical

Intervention Description

Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.

Primary Outcome Measure Information:

Title

Change in Pain Scale

Description

Time Frame

Measured for approximately 6 months

Secondary Outcome Measure Information:

Title

Changes in Quality of Life Scale

Description

Time Frame

Measured for approximately 6 months

Title

Changes in Mood Scale

Description

Time Frame

Measured for approximately 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Over 18 years of age History of moderate to severe sublesional pain Exclusion Criteria: Active alcohol or drug dependence, as self-reported A history of bipolar disorder or psychosis, as self-reported Inability to travel to the study site, Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment [53]: carbamazepine, oxcarbazepine, phenytoin, ropinirole (Requip), pramipexole (Mirapex), and cabergoline (Dostinex), The following contradictions to tDCS: implanted metal plates in the head, or deep brain stimulator (spinal cord implants, including baclofen pumps, are not a contraindication as cranial currents do not reach the spinal cord [24]). Pregnancy at time of enrollment Current use of ventilator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felipe Fregni, MD PHD MPH

Organizational Affiliation

Spaulding Rehabilitation Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Spaulding Rehabilitation Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28822837

Citation

Thibaut A, Carvalho S, Morse LR, Zafonte R, Fregni F. Delayed pain decrease following M1 tDCS in spinal cord injury: A randomized controlled clinical trial. Neurosci Lett. 2017 Sep 29;658:19-26. doi: 10.1016/j.neulet.2017.08.024. Epub 2017 Aug 16.

Results Reference

derived

Links:

URL

http://www.sh-sci.org

Description

Spaulding-Harvard SCI Model System Website

Learn more about this trial

Spaulding-Harvard Model System: Effects of Transcranial Direct Current Stimulation (tDCS) on Chronic Pain in Spinal Cord Injury

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