Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients

N/ACompletedNCT01842009

Spaulding Rehabilitation Hospital20 enrolled

Overview

The purpose of this study is to investigate the mean number of stimulation (high definition-transcranial direct current stimulation) sessions (up to 26) needed to achieve a clinical response with this response defined as a 50% decrease in Visual Analog Scale (VAS) for pain. These data will be important in defining the optimal number of sessions for future fibromyalgia subjects in Phase III trials.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fibromyalgia Chronic Pain

Interventions

High Definition transcranial Direct Current StimulationDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Providing informed consent to participate in the study * 18 to 85 years old, both male and female * Have a diagnosis of Fibromyalgia * Existing pain for more than 3 months with an average of at least 4 on a 0-10 VAS scale * Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex and Codeine. Exclusion Criteria: * Pregnancy * Contraindications to tDCS: metal in the head or implanted brain medical devices * History of alcohol or drug abuse within the past 6 months as self-reported * Use of carbamazepine within the past 6 months as self-reported * Severe depression (with a score of \>30 in the Beck Depression Inventory) * Any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or severe migraines * History of unexplained fainting spells as self-reported * Neurosurgery as self-reported

Locations (1)

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, United States

Outcomes

Primary Outcomes

Mean number of sessions needed to achieve 50% decrease in Visual Analogue Scale (VAS)

Investigate the mean number of sessions (up to 26) needed to achieve clinical response associated with the use of HD-tDCS over the primary motor cortex (M1), with response defined at a 50% decrease in baseline Visual Analogue Scale (VAS) for pain.

Time frame: approximately 4.5 months

Secondary Outcomes

Number of subjects who achieve clinical response

We will count the number of subjects who achieve clinical response (as defined in Aim 1 as a 50% reduction in baseline VAS) for the duration of the trial.

Time frame: Approximately 4.5 months

Measurement of sensory and auditory evoked potentials

We will measure brain pain response using electroencephalography (EEG) to measure somatosensory Event Related Potentials (ERPs) with a heat pain threshold device. We will also measure auditory ERPs. We will investigate the relationship between these ERP measurements and overall clinical response of patients (as outlined in Aim 1 and Aim 2)

Time frame: Approximately 4.5 months

Data from ClinicalTrials.gov

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