Effects of Direct Transcranial Current Stimulation on Central Neural Pain Processing in Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT01745003|
Recruitment Status : Completed
First Posted : December 7, 2012
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Procedure: Transcranial Direct Current Stimulation (tDCS)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Direct Transcranial Current Stimulation on Central Neural Pain Processing in Fibromyalgia|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Investigate biochemical, functional, and structural neuroimaging changes following non-invasive brain stimulation in patients with chronic widespread pain: fibromyalgia (FM). We will be using tDCS as intervention.
Procedure: Transcranial Direct Current Stimulation (tDCS)
tDCS is based on the application of a weak direct current to the scalp that flows between two relatively large electrodes—anode and cathode. We will be using this device to investigate fibromyalgia.
- Glu levels within the insula and thalamus will be reduced following tDCS [ Time Frame: 3rd MRI (week 5 of patient participation) ]Determine the effects of tDCS on the excitatory neurotransmitter glutamate (Glu) within the insula (posterior and anterior) and thalamus in individuals with FM. Glu levels within the insula and thalamus will be reduced following tDCS, reflecting a down regulation of excitatory neurotransmission in these pain regions.
- Cortical thickness in FM patients, will return to comparable age- and sex-matched pain-free control participant levels following tDCS [ Time Frame: 3rd MRI (week 5 of patient participation) ]Investigate whether long-term therapy with tDCS normalizes gray matter thickness in target and cortical areas associated with pain perception and modulation in FM. Cortical thickness in FM patients, will return to comparable age- and sex-matched pain-free control participant levels following tDCS. These effects will be specifically detected in pain modulatory regions (e.g. dorsal lateral prefrontal cortex) of FM patients
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): NCT01745003
|United States, Michigan|
|University of Michigan - Michigan Center for Oral Health Research|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator:||Alexandre DaSilva, DDS, MS||University of Michigan|