Skip to main content
OpenTrials
Completed

NCT Number: NCT01402960

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Definition transcranial direct current stimulation (HD-tDCS)

Device

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 outcomes

  1. Change in pain scales

    Time frame: Measured for approximately 5 weeks

    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 outcomes

  1. Change in cutaneous hyperalgesia/allodynia

    Time frame: Measured for approximately 5 weeks.

    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.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

Exploration of Parameters of tDCS in Chronic Pain Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 26, 2011
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.