NCT01842009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2016

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

1.3 years

First QC Date

April 18, 2013

Last Update Submit

April 23, 2020

Conditions

FibromyalgiaChronic Pain

Keywords

transcranial stimulationdirect current

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of subjects who achieve clinical response

    Approximately 4.5 months

  • Measurement of sensory and auditory evoked potentials

    Approximately 4.5 months

Study Arms (1)

Active anodal HD-tDCS

EXPERIMENTAL

Subjects will undergo 20 minutes active HD-tDCS.

Device: High Definition transcranial Direct Current Stimulation

Interventions

High Definition transcranial Direct Current StimulationDEVICE
Also known as: 4X1 low-intensity direct current stimulator
Active anodal HD-tDCS

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Providing informed consent to participate in the study
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (1)

  • 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.

    PMID: 26456677DERIVED

MeSH Terms

Conditions

FibromyalgiaChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Felipe Fregni, MD PhD MPH

    Spaulding Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 18, 2013

First Posted

April 29, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2014

Study Completion

June 7, 2016

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

US(1)