Effects of Direct Transcranial Current Stimulation on Central Neural Pain Processing in Fibromyalgia

• Sponsor: University of Michigan
• Information provided by (Responsible Party): Alexandre DaSilva, DDS, MS, University of Michigan

Study Description

Brief Summary:

The main goal of this Collaborative Proposal is to investigate biochemical, functional, and structural neuroimaging changes following non-invasive brain stimulation in patients with chronic widespread pain: fibromyalgia (FM). The fact that multiple therapeutic modalities which focus on central mechanisms provide modest relief for these patients raises the possibility that the cause for the chronicity of this debilitating disorder may lie within the brain itself. We propose that changes in the cortical milieu may result from prolonged experience of pain and suffering. Our previous results suggest changes in excitatory neurotransmitter levels, connectivity between multiple brain networks, and cortical thickness coincide within central neural loci related to pain perception and modulation in FM. Interestingly, modulation of cortical activity can be achieved noninvasively by a novel tool, transcranial direct current stimulation (tDCS), which has been reported to produce lasting therapeutic effects in chronic pain, especially FM. We propose to study the long-term effects of tDCS application on multiple levels of the central nervous system in FM patients. This project has significant clinical relevance and has the support of collaborators from University of Michigan and Harvard University

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Procedure: Transcranial Direct Current Stimulation (tDCS)	Phase 1; Phase 2

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Study Design

• 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

Arms and Interventions

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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

The inclusion criteria are:

1. 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
2. Continued presence of pain more than 50% of days
3. Willingness to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study
4. Being over 18 and under 65 years of age
5. BMI of 36 or less (because we use the MRI machine)
6. Capability of giving written informed consent

The exclusion criteria are:

1. Presence of concurrent autoimmune or inflammatory disease; such as, rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, etc. that causes pain
2. Routine daily use of narcotic analgesics or history of substance abuse
3. Concurrent participation in other therapeutic trials
4. Pregnant and nursing mothers (verification of pregnancy status will be determined via a urine test)
5. Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years)
6. Contraindications to fMRI, or H-MRS methods
7. Any impairment, activity or situation that in the judgment of the Study Coordinator or PI would prevent satisfactory completion of the study protocol

Contacts and Locations

Locations

United States, Michigan

University of Michigan - Michigan Center for Oral Health Research

Ann Arbor, Michigan, United States, 48106

Sponsors and Collaborators

University of Michigan

Investigators

• Principal Investigator: Alexandre DaSilva, DDS, MS; University of Michigan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Foerster BR, Nascimento TD, DeBoer M, Bender MA, Rice IC, Truong DQ, Bikson M, Clauw DJ, Zubieta JK, Harris RE, DaSilva AF. Excitatory and inhibitory brain metabolites as targets of motor cortex transcranial direct current stimulation therapy and predictors of its efficacy in fibromyalgia. Arthritis Rheumatol. 2015 Feb;67(2):576-81.

• 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
• 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