The Effects of CBT and tDCS on Fibromyalgia Patients

NCT02723175 | Completed Results DMC

• 2 other identifiers: Pro000396031R21AR066428-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia; Chronic Pain

Keywords

Fibromyalgia; Pain

Outcome Measures

Primary Outcomes (2)

• Baseline Quantitative Sensory Testing (QST)

  Before treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.

  Before Treatment

• Post Baseline Quantitative Sensory Testing (QST)

  After treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.

  One week Post Treatment

Secondary Outcomes (16)

• The Beck Depression Inventory (BDI) at Baseline

  Before Treatment

• The Beck Anxiety Inventory (BAI) at Baseline

  Before Treatment

• Brief Pain Inventory-Average Pain at Baseline

  Before Treatment

• Percent Change in Average Daily Pain at Treatment Visit 3

  Treatment Session 3 (week 3)

• Affective Subscale of McGill Pain Questionnaire at Baseline

  Before Treatment

Study Arms (2)

Sham tDCS Stimulation

EXPERIMENTAL

30 minutes of the sham transcranial Direct Current Stimulation 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.

Device: Transcranial Direct Current Stimulation

Anodal tDCS Stimulation of DLPFC

EXPERIMENTAL

30 minutes of the active transcranial Direct Current Stimulation (tDCS) 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.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

Anodal tDCS Stimulation of DLPFC; Sham tDCS Stimulation

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other chronic pain conditions
• on chronic opioid therapy
• history of seizures
• are or might be pregnant
• metal/electronic implants or devices above the waist
• moderate to severe depression (HDRS \>19)
• moderate to severe anxiety (BAI \>16)
• Latex allergy
• Psychiatric illness other than mild depression or anxiety
• on medications that lower seizure threshold

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Jeffrey Borckardt
• Organization: Medical University of South Carolina

borckard@musc.edu

843-792-3295

Study Officials

• Jeffrey Borckardt, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: March 30, 2016
• Study Start: December 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: September 1, 2017
• Last Updated: November 28, 2018
• Results First Posted: November 28, 2018

Record last verified: 2018-10

Locations

US (1)