Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain
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ClinicalTrials.gov Identifier: NCT01402960 |
Recruitment Status :
Completed
First Posted : July 26, 2011
Last Update Posted : April 24, 2020
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Condition or disease | Intervention/treatment | Phase |
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Chronic Pain | Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Device Feasibility |
Official Title: | Exploration of Parameters of tDCS in Chronic Pain Patients |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | February 13, 2013 |

Arm | Intervention/treatment |
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Experimental: Active Anodal HD-tDCS
Subject will receive one 20-minute session of active anodal HD-tDCS.
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Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)
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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Experimental: Active Cathodal HD-tDCS
Subject will receive one 20-minute session of active cathodal HD-tDCS.
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Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)
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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Sham Comparator: Sham HD-tDCS
Subject will receive one sham session of HD-tDCS
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Device: High Definition Transcranial Direct Current Stimulation (HD-tDCS)
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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- Change in pain scales [ Time Frame: 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.
- Change in cutaneous hyperalgesia/allodynia [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
STUDY ELIGIBILITY CRITERIA
Inclusion Criteria:
- Providing informed consent to participate in the study
- 18 to 64 years old
- Having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
- Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
- Must have the ability to feel pain as self reported
Exclusion Criteria:
- Pregnancy
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Contraindications to tDCS
- metal in the head
- implanted brain medical devices
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402960
United States, Massachusetts | |
Spaulding Rehabilitation Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Felipe Fregni, MD, PhD, MPH | Spaulding Rehabilitation Hospital (SRH) |
Responsible Party: | Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital |
ClinicalTrials.gov Identifier: | NCT01402960 |
Other Study ID Numbers: |
2010-p-000990 |
First Posted: | July 26, 2011 Key Record Dates |
Last Update Posted: | April 24, 2020 |
Last Verified: | April 2020 |
Studies a U.S. FDA-regulated Device Product: | No |
High-Definition Transcranial Direct Current Stimulation |
Chronic Pain Pain Neurologic Manifestations |