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

Primary Purpose

Fibromyalgia, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Definition transcranial Direct Current Stimulation
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring transcranial stimulation, direct current

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active anodal HD-tDCS

Arm Description

Subjects will undergo 20 minutes active HD-tDCS.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)

Full Information

First Posted
April 18, 2013
Last Updated
April 23, 2020
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
ElMindA Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01842009
Brief Title
Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
Official Title
Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
June 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
ElMindA Ltd

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Pain
Keywords
transcranial stimulation, direct current

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active anodal HD-tDCS
Arm Type
Experimental
Arm Description
Subjects will undergo 20 minutes active HD-tDCS.
Intervention Type
Device
Intervention Name(s)
High Definition transcranial Direct Current Stimulation
Other Intervention Name(s)
4X1 low-intensity direct current stimulator
Primary Outcome Measure Information:
Title
Mean number of sessions needed to achieve 50% decrease in Visual Analogue Scale (VAS)
Description
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 Outcome Measure Information:
Title
Number of subjects who achieve clinical response
Description
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
Title
Measurement of sensory and auditory evoked potentials
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD PhD MPH
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26456677
Citation
Castillo-Saavedra L, Gebodh N, Bikson M, Diaz-Cruz C, Brandao R, Coutinho L, Truong D, Datta A, Shani-Hershkovich R, Weiss M, Laufer I, Reches A, Peremen Z, Geva A, Parra LC, Fregni F. Clinically Effective Treatment of Fibromyalgia Pain With High-Definition Transcranial Direct Current Stimulation: Phase II Open-Label Dose Optimization. J Pain. 2016 Jan;17(1):14-26. doi: 10.1016/j.jpain.2015.09.009. Epub 2015 Oct 9.
Results Reference
derived

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

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