Status:
COMPLETED
Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System
Lead Sponsor:
Spaulding Rehabilitation Hospital
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This trial aims at understanding the mechanisms of optimized transcranial direct current stimulation (tDCS) (16 tDCS sessions combined with exercise)\] on pain control. Optimized tDCS can lead to stro...
Detailed Description
Recent evidence has suggested that FM pain can be related to deficits in pain endogenous regulatory control and that novel non-pharmacological interventions, such as tDCS can modulate this system and,...
Eligibility Criteria
Inclusion
- Age range 18-65 years,
- Diagnosis of FM pain according to the ACR 2010 criteria (existing pain for more than 6 months with an average of at least 4 on a 0-10 VAS scale) without other comorbid chronic pain diagnosis,
- 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 sensation by Von-Frey fiber on the forearm,
- Able to provide informed consent to participate in the study.
Exclusion
- Clinically significant or unstable medical or psychiatric disorder,
- history of substance abuse within the past 6 months as self-reported (if subject reports a history of substance abuse, we will confirm using DSM V criteria),
- Previous significant neurological history (e.g., traumatic brain injury), resulting in neurological deficits, such as cognitive or motor deficits, as self-reported,
- Previous neurosurgical procedure with craniotomy,
- Severe depression (If a patient scores \>30 on the Beck Depression Inventory, one will obtain clearance. If one does not pass the medical clearance, one will not be included in the study)
- Pregnancy (as the safety of tDCS in pregnant population (and children) has not been assessed (though risk is non-significant), the investigators will exclude pregnant women (and children). Women of child-bearing potential will be required to take a urine pregnancy test during the screening process and at every week of stimulation),
- Current opiate use in large doses (more than 30mg of oxycodone/hydrocodone or 7.5mg of hydromorphone (Dilaudid) or equivalent),
- Patients will be excluded when they have increased risk for exercise
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2025
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03371225
Start Date
May 1 2019
End Date
October 26 2025
Last Update
December 10 2025
Active Locations (1)
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1
Spaulding Rehabilitation Hospital for Continuing Care
Cambridge, Massachusetts, United States, 02138