Trial record 8 of 111 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Alexandre DaSilva, DDS, MS, University of Michigan
ClinicalTrials.gov Identifier:
NCT01745003
First received: December 4, 2012
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Fibromyalgia
Procedure: Transcranial Direct Current Stimulation (tDCS)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effects of Direct Transcranial Current Stimulation on Central Neural Pain Processing in Fibromyalgia

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Glu levels within the insula and thalamus will be reduced following tDCS [ Time Frame: 3rd MRI (week 5 of patient participation) ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745003

Contacts
Contact: Alexandre F DaSilva, DDS, DMedS (734) 615 - 9390 contactHOPE@umich.edu

Locations
United States, Michigan
University of Michigan - Michigan Center for Oral Health Research Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Alexandre DaSilva, DDS, MS    734-615-9390    contactHOPE@umich.edu   
Principal Investigator: Alexandre DaSilva, DDS, MS         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Alexandre DaSilva, DDS, MS University of Michigan
  More Information

No publications provided

Responsible Party: Alexandre DaSilva, DDS, MS, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01745003     History of Changes
Other Study ID Numbers: HUM00041993
Study First Received: December 4, 2012
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 27, 2014