Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound on Osteoarthritis Pain of the Knee

NCT01404052 | Completed

• 1 other identifier: 2010-p-001977
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with osteoarthritis of the knee. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation. Before, during and after stimulation, the investigators will measure and assess changes intracranial blood flow with transcranial ultrasound.

Conditions

Chronic Pain; Osteoarthritis

Keywords

transcranial direct current stimulation; transcranial ultrasound

Outcome Measures

Primary Outcomes (1)

• Changes in pain scale

  Determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain in subjects with chronic osteoarthritis pain, as measured by changes in the Visual Analogue Scale (VAS) for pain. VAS will be measured immediately before the tDCS stimulation sessions, and immediately after the tDCS stimulation sessions for the subject's duration in the trial. VAS will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)

  Measured for approximately 2 months

Secondary Outcomes (2)

• Changes in cutaneous allodynia/hyperalgesia

  Measured for approximately 2 months

• Assessment of hemodynamic changes with transcranial ultrasound

  Measured for approximately 2 months

Study Arms (2)

Active tDCS + transcranial ultrasound

EXPERIMENTAL

Subjects will undergo 20 minutes active tDCS in conjunction with transcranial ultrasound measurements.

Device: Transcranial Direct Current Stimulation

Sham tDCS + transcranial ultrasound

SHAM COMPARATOR

Subjects will receive sham tDCS in conjunction with transcranial ultrasound measurements.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

Subjects will be randomized to undergo either 5 sessions of active tDCS stimulation, or 5 sessions of sham tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm\^2 and an intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. Active stimulation will last for 20 minutes, while sham stimulation will only last for 30 seconds, mimicking the sensations during active stimulation.

Also known as: low intensity 1x1 direct current stimulator

Active tDCS + transcranial ultrasound; Sham tDCS + transcranial ultrasound

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Providing informed consent to participate in the study
• to 64 years old
• Having chronic osteoarthritis knee pain in either knee (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

You may not qualify if:

• Subject is pregnant.
• Contraindications to tDCS:
• metal in the head
• implanted brain medical devices
• Contraindications to TUS:
• 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.
• Suffering from 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Highland Instruments, Inc.: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Felipe Fregni, MD, PhD, MPH

  Spaulding Rehabilitation Hospital (SRH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 27, 2011
• Study Start: January 1, 2011
• Primary Completion: July 30, 2014
• Study Completion: July 30, 2014
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)