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

Mass General Brigham

Status: Completed

Conditions: Chronic Pain

Treatments: Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01402960

2010-p-000990

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

STUDY ELIGIBILITY CRITERIA

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 3 patient groups

Active Anodal HD-tDCS

Experimental group

Description:

Subject will receive one 20-minute session of active anodal HD-tDCS.

Treatment:

Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)

Active Cathodal HD-tDCS

Experimental group

Description:

Subject will receive one 20-minute session of active cathodal HD-tDCS.

Treatment:

Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)

Sham HD-tDCS

Sham Comparator group

Description:

Subject will receive one sham session of HD-tDCS

Treatment:

Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)