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
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Condition or disease | Intervention/treatment | Phase |
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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) |
Primary Purpose: | Diagnostic |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Fibromyalgia
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.
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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.
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- 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
The inclusion criteria are:
- Women who have met American College of Rheumatology (1990) criteria for the diagnosis of FM (Wolfe, Smythe et al. 1990) for at least 1 year. To fulfill the criteria for FM established by the American College of Rheumatology in 1990, an individual must have both chronic widespread pain involving all four quadrants of the body (and the axial skeleton), and the presence of 11 of 18 pre-defined "tender points" on examination. A positive tender point is identified when an individual complains of pain when approximately four kilograms of pressure is applied to one of these points by an examiner
- Continued presence of pain more than 50% of days
- Willingness to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study
- Being over 18 and under 65 years of age
- BMI of 36 or less (because we use the MRI machine)
- Capability of giving written informed consent
The exclusion criteria are:
- Presence of concurrent autoimmune or inflammatory disease; such as, rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, etc. that causes pain
- Routine daily use of narcotic analgesics or history of substance abuse
- Concurrent participation in other therapeutic trials
- Pregnant and nursing mothers (verification of pregnancy status will be determined via a urine test)
- Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years)
- Contraindications to fMRI, or H-MRS methods
- Any impairment, activity or situation that in the judgment of the Study Coordinator or PI would prevent satisfactory completion of the study protocol

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Alexandre DaSilva, DDS, MS, Assistant Professor, University of Michigan |
ClinicalTrials.gov Identifier: | NCT01745003 History of Changes |
Other Study ID Numbers: |
HUM00041993 |
First Posted: | December 7, 2012 Key Record Dates |
Last Update Posted: | November 24, 2017 |
Last Verified: | November 2017 |
Keywords provided by Alexandre DaSilva, DDS, MS, University of Michigan:
Fibromyalgia |
Additional relevant MeSH terms:
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |