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

Not Applicable

Completed

• Conditions: Spinal Cord Injury; Chronic Pain; Neuropathic Pain

• Registration Number: NCT01599767
• Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-16
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain Scale	Measured for approximately 6 months	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

Name	Time	Method
Changes in Quality of Life Scale	Measured for approximately 6 months	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	Measured for approximately 6 months	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).

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States