Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)

• Registration Number: NCT01402960
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary

The purpose of this study is to assess the effects of high-definition transcranial direct current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham stimulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Primary Completion: 2012-02
• Study Completion: 2013-02-13
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Providing informed consent to participate in the study
2. 18 to 64 years old
3. Having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
4. Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
5. Must have the ability to feel pain as self reported

Exclusion Criteria

1. Pregnancy

2. Contraindications to tDCS

   • metal in the head
   • implanted brain medical devices

3. History of alcohol or drug abuse within the past 6 months as self reported

4. Use of carbamazepine within the past 6 months as self reported.

5. Severe depression (with a score of >30 in the Beck Depression Inventory)

6. History of neurological disorders as self reported.

7. History of unexplained fainting spells as self reported,

8. History of head injury resulting in more than a momentary loss of consciousness as self reported

9. History of neurosurgery as self reported

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham HD-tDCS	High Definition Transcranial Direct Current Stimulation (HD-tDCS)	Subject will receive one sham session of HD-tDCS
Active Anodal HD-tDCS	High Definition Transcranial Direct Current Stimulation (HD-tDCS)	Subject will receive one 20-minute session of active anodal HD-tDCS.
Active Cathodal HD-tDCS	High Definition Transcranial Direct Current Stimulation (HD-tDCS)	Subject will receive one 20-minute session of active cathodal HD-tDCS.

Primary Outcome Measures

Name	Time	Method
Change in pain scales	Measured for approximately 5 weeks	Determine whether anodal or cathodal hd-tDCS is effective in reducing pain in subjects with chronic musculoskeletal pain as measured by changes in the Visual Analogue Scale (VAS) for pain. The VAS scale will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for each subject for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Change in cutaneous hyperalgesia/allodynia	Measured for approximately 5 weeks.	To investigate whether treatment with active anodal hd-tDCS alters the phenomenon of central sensitization as indexed by cutaneous allodynia and hyperalgesia by measuring whether anodal tDCS changes the threshold for pain and perception as compared with sham and cathodal hd-tDCS. The subject's pain threshold will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.

Trial Locations

Locations (1)

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