The Effects of CBT and tDCS on Fibromyalgia Patients

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Fibromyalgia; Chronic Pain

Treatments: Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02723175

1R21AR066428-01 (U.S. NIH Grant/Contract)

Pro00039603

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Sham tDCS Stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Anodal tDCS Stimulation of DLPFC

Experimental group

Description:

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.

Treatment:

Device: Transcranial Direct Current Stimulation