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Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain

Primary Purpose

Chronic Pain

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

About this trial

This is an interventional device feasibility trial for Chronic Pain focused on measuring High-Definition Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

STUDY ELIGIBILITY CRITERIA

Inclusion Criteria:

  1. Providing informed consent to participate in the study
  2. 18 to 64 years old
  3. Having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
  4. Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
  5. Must have the ability to feel pain as self reported

Exclusion Criteria:

  1. Pregnancy

  2. Contraindications to tDCS

    • metal in the head
    • implanted brain medical devices
  3. History of alcohol or drug abuse within the past 6 months as self reported
  4. Use of carbamazepine within the past 6 months as self reported.
  5. Severe depression (with a score of >30 in the Beck Depression Inventory)
  6. History of neurological disorders as self reported.
  7. History of unexplained fainting spells as self reported,
  8. History of head injury resulting in more than a momentary loss of consciousness as self reported
  9. History of neurosurgery as self reported

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Active Anodal HD-tDCS

Active Cathodal HD-tDCS

Sham HD-tDCS

Arm Description

Subject will receive one 20-minute session of active anodal HD-tDCS.

Subject will receive one 20-minute session of active cathodal HD-tDCS.

Subject will receive one sham session of HD-tDCS

Outcomes

Primary Outcome Measures

Change in pain scales
Determine whether anodal or cathodal hd-tDCS is effective in reducing pain in subjects with chronic musculoskeletal pain as measured by changes in the Visual Analogue Scale (VAS) for pain. The VAS scale will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for each subject for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.

Secondary Outcome Measures

Change in cutaneous hyperalgesia/allodynia
To investigate whether treatment with active anodal hd-tDCS alters the phenomenon of central sensitization as indexed by cutaneous allodynia and hyperalgesia by measuring whether anodal tDCS changes the threshold for pain and perception as compared with sham and cathodal hd-tDCS. The subject's pain threshold will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.

Full Information

First Posted
June 29, 2011
Last Updated
April 23, 2020
Sponsor
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01402960
Brief Title
Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain
Official Title
Exploration of Parameters of tDCS in Chronic Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 13, 2013 (Actual)

3. Sponsor/Collaborators

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

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 assess the effects of high-definition transcranial direct current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
High-Definition Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Anodal HD-tDCS
Arm Type
Experimental
Arm Description
Subject will receive one 20-minute session of active anodal HD-tDCS.
Arm Title
Active Cathodal HD-tDCS
Arm Type
Experimental
Arm Description
Subject will receive one 20-minute session of active cathodal HD-tDCS.
Arm Title
Sham HD-tDCS
Arm Type
Sham Comparator
Arm Description
Subject will receive one sham session of HD-tDCS
Intervention Type
Device
Intervention Name(s)
High Definition Transcranial Direct Current Stimulation (HD-tDCS)
Intervention Description
Subject will receive active anodal/cathodal and sham HD-tDCS in a randomized, counterbalanced order. Each stimulation session will be separated by at least one week to avoid carryover effects. For both active and sham HD-tDCS the electrodes will be placed over the primary motor cortex, at an intensity of 2mA. For active anodal stimulation, the anode will be over the primary motor cortex, and the cathodal electrodes (4) will surround the anode in a 3 inch square, duration will be 20 minutes. For active cathodal stimulation, the cathode will be over the primary motor cortex, and the anodal electrodes (4) will surround the cathode in a 3 inch square, duration will be 20 minutes. For sham stimulation, the same procedure will be used, however, current will only be active for 30 seconds (current ramping up, then ramping down)
Primary Outcome Measure Information:
Title
Change in pain scales
Description
Determine whether anodal or cathodal hd-tDCS is effective in reducing pain in subjects with chronic musculoskeletal pain as measured by changes in the Visual Analogue Scale (VAS) for pain. The VAS scale will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for each subject for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.
Time Frame
Measured for approximately 5 weeks
Secondary Outcome Measure Information:
Title
Change in cutaneous hyperalgesia/allodynia
Description
To investigate whether treatment with active anodal hd-tDCS alters the phenomenon of central sensitization as indexed by cutaneous allodynia and hyperalgesia by measuring whether anodal tDCS changes the threshold for pain and perception as compared with sham and cathodal hd-tDCS. The subject's pain threshold will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.
Time Frame
Measured for approximately 5 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
STUDY ELIGIBILITY CRITERIA Inclusion Criteria: Providing informed consent to participate in the study 18 to 64 years old Having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 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. Must have the ability to feel pain as self reported Exclusion Criteria: Pregnancy Contraindications to tDCS metal in the head 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) History of neurological disorders as self reported. History of unexplained fainting spells as self reported, History of head injury resulting in more than a momentary loss of consciousness as self reported History of neurosurgery as self reported
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD, PhD, MPH
Organizational Affiliation
Spaulding Rehabilitation Hospital (SRH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain

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