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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Anodal HD-tDCS | Experimental | Subject will receive one 20-minute session of active anodal HD-tDCS. |
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| Active Cathodal HD-tDCS | Experimental | Subject will receive one 20-minute session of active cathodal HD-tDCS. |
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| Sham HD-tDCS | Sham Comparator | Subject will receive one sham session of HD-tDCS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Definition Transcranial Direct Current Stimulation (HD-tDCS) | Device | Subject will receive active anodal/cathodal and sham HD-tDCS in a randomized, counterbalanced order. Each stimulation session will be separated by at least one week to avoid carryover effects. For both active and sham HD-tDCS the electrodes will be placed over the primary motor cortex, at an intensity of 2mA.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in pain scales | 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. | Measured for approximately 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cutaneous hyperalgesia/allodynia | 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. |
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STUDY ELIGIBILITY CRITERIA
Inclusion Criteria:
Exclusion Criteria:
Pregnancy
Contraindications to tDCS
History of alcohol or drug abuse within the past 6 months as self reported
Use of carbamazepine within the past 6 months as self reported.
Severe depression (with a score of >30 in the Beck Depression Inventory)
History of neurological disorders as self reported.
History of unexplained fainting spells as self reported,
History of head injury resulting in more than a momentary loss of consciousness as self reported
History of neurosurgery as self reported
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Fregni, MD, PhD, MPH | Spaulding Rehabilitation Hospital (SRH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Measured for approximately 5 weeks. |