Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
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|ClinicalTrials.gov Identifier: NCT01842009|
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia Chronic Pain||Device: High Definition transcranial Direct Current Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients|
|Actual Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||June 7, 2016|
Experimental: Active anodal HD-tDCS
Subjects will undergo 20 minutes active HD-tDCS.
Device: High Definition transcranial Direct Current Stimulation
Other Name: 4X1 low-intensity direct current stimulator
- Mean number of sessions needed to achieve 50% decrease in Visual Analogue Scale (VAS) [ Time Frame: approximately 4.5 months ]Investigate the mean number of sessions (up to 26) needed to achieve clinical response associated with the use of HD-tDCS over the primary motor cortex (M1), with response defined at a 50% decrease in baseline Visual Analogue Scale (VAS) for pain.
- Number of subjects who achieve clinical response [ Time Frame: Approximately 4.5 months ]We will count the number of subjects who achieve clinical response (as defined in Aim 1 as a 50% reduction in baseline VAS) for the duration of the trial.
- Measurement of sensory and auditory evoked potentials [ Time Frame: Approximately 4.5 months ]We will measure brain pain response using electroencephalography (EEG) to measure somatosensory Event Related Potentials (ERPs) with a heat pain threshold device. We will also measure auditory ERPs. We will investigate the relationship between these ERP measurements and overall clinical response of patients (as outlined in Aim 1 and Aim 2)
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): NCT01842009
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital|
|Charlestown, Massachusetts, United States, 02129|
|Principal Investigator:||Felipe Fregni, MD PhD MPH||Spaulding Rehabilitation Hospital|