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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842009
• Other study ID #: 2013P000384
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: June 7, 2016

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 7, 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• High Definition transcranial Direct Current Stimulation

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Charlestown	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	ElMindA Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 4.5 months
Secondary	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.	Approximately 4.5 months
Secondary	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)	Approximately 4.5 months