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Trial record 18 of 97 for:    fibromyalgia | Open Studies | Interventional Studies

The Effects of CBT and (tDCS) on Fibromyalgia Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Medical University of South Carolina
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT02723175
First received: December 14, 2015
Last updated: March 23, 2016
Last verified: November 2015
  Purpose
Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and combined CBT+ tDCS on clinical pain and functioning among a sample of patients with fibromyalgia. This study will be the first randomized, double-blind, controlled study of tDCS technology as an adjunctive pain management strategy for fibromyalgia pain. Data from this trial will likely yield information regarding the feasibility and efficacy of tDCS+CBT as a chronic pain-management approach.

Condition Intervention
Fibromyalgia
Chronic Pain
Device: Transcranial Direct Current Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Cognitive Behavioral Therapy and Transcranial Direct Current Stimulation (tDCS) on Fibromyalgia Patients

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Quantitative Sensory Testing [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Participants will undergo comprehensive laboratory pain assessment including hot sensory and pain thresholds using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing.


Secondary Outcome Measures:
  • The Beck Depression Inventory [ Time Frame: 5 mintues ] [ Designated as safety issue: No ]
    well-researched, brief self-report depression-screening instrument. This instrument will be used for screening purposes in the laboratory study and to characterize depression in the clinical cohort. The BDI scale assesses suicidal ideation, those patients exhibiting suicidal ideations will be referenced to a therapist in order to further manage their depressive symptoms.

  • The Beck Anxiety Inventory [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    well-researched, brief self-report anxiety-screening instrument. It assesses different aspects of anxiety experience (e.g., physiological, cognitive, behavioral).

  • The Brief Pain Inventory [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    a self-report questionnaire designed to assess pain intensity and the impact of pain on general functioning, relationships and mood

  • Daily pain diaries [ Time Frame: through study completion, an average of 6 months. ] [ Designated as safety issue: No ]
    administered via paper and pencil to patients in the clinical pilot Diaries will assess daily (via VAS) average pain, pain at its worst, pain unpleasantness, mood, activity level, and will capture hours of sleep and sleep quality ratings.

  • The Mcgill Pain Questionnaire [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    self-report scale designed to capture the quality and intensity of pain experience. The ratings load onto 4 factors: 1) Sensory, 2) Affective, 3) Evaluative, and 4) Miscellaneous.

  • The Short-Form 12 Healthy Survey [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    used to assess quality of life across the eight QOL domains captured with the measure during the trial.

  • The Fibromyalgia Impact Questionnaire [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    used to assess pain symptoms and functioning specific to FM.


Estimated Enrollment: 72
Study Start Date: November 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sham tDCS Stimulation
30 minutes of the sham transcranial Direct Current Stimulation
Device: Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.
Experimental: Anodal tDCS Stimulation of DLPFC
30 minutes of the active transcranial Direct Current Stimulation (tDCS)
Device: Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Detailed Description:
Patients with fibromyalgia will complete questionnaires, six cognitive behavioral therapy sessions, quantitative sensory testing before and after the six therapy sessions, and undergo 30 minutes of tDCS during each of the six therapy sessions.
  Eligibility

Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet the American College of Rheumatology criteria for diagnosis of fibromyalgia for at least 1 year.
  2. Between the ages of 21 and 85

Exclusion Criteria:

  1. Other chronic pain conditions
  2. on chronic opioid therapy
  3. history of seizures
  4. are or might be pregnant
  5. metal/electronic implants or devices above the waist
  6. moderate to severe depression (HDRS >19)
  7. moderate to severe anxiety (BAI >16)
  8. Latex allergy
  9. Psychiatric illness other than mild depression or anxiety
  10. on medications that lower seizure threshold
  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: NCT02723175

Contacts
Contact: Jeffrey Borckardt, Ph.D. 843-792-3295 borckard@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jeffery Borckardt, PhD    843-792-3127      
Principal Investigator: Jeffery Borckardt, PhD         
Sponsors and Collaborators
Medical University of South Carolina
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Jeffrey Borckardt, Ph.D. Medical University of South Carolina
  More Information

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02723175     History of Changes
Other Study ID Numbers: Pro00039603  1R21AR066428-01 
Study First Received: December 14, 2015
Last Updated: March 23, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Fibromyalgia
Pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on December 06, 2016