Overview

This trial is active, not recruiting.

Conditions chronic pain, osteoarthritis
Treatment transcranial direct current stimulation
Phase phase 1
Sponsor Spaulding Rehabilitation Hospital
Collaborator Highland Instruments, Inc.
Start date January 2011
End date December 2016
Trial size 30 participants
Trial identifier NCT01404052, 2010-p-001977

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Subjects will undergo 20 minutes active tDCS in conjunction with transcranial ultrasound measurements.
transcranial direct current stimulation low intensity 1x1 direct current stimulator
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.
(Sham Comparator)
Subjects will receive sham tDCS in conjunction with transcranial ultrasound measurements.
transcranial direct current stimulation low intensity 1x1 direct current stimulator
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.

Primary Outcomes

Measure
Changes in pain scale
time frame: Measured for approximately 2 months

Secondary Outcomes

Measure
Changes in cutaneous allodynia/hyperalgesia
time frame: Measured for approximately 2 months
Assessment of hemodynamic changes with transcranial ultrasound
time frame: Measured for approximately 2 months

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

STUDY ELIGIBILITY CRITERIA Inclusion Criteria: 1. Providing informed consent to participate in the study 2. 18 to 64 years old 3. 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) 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. Subject is pregnant. 2. Contraindications to tDCS: - metal in the head - implanted brain medical devices 3. Contraindications to TUS: - metal in the head - implanted brain medical devices 4. History of alcohol or drug abuse within the past 6 months as self reported 5. Use of carbamazepine within the past 6 months as self reported. 6. Suffering from severe depression (with a score of >30 in the Beck Depression Inventory) 7. History of neurological disorders as self reported. 8. History of unexplained fainting spells as self reported, 9. History of head injury resulting in more than a momentary loss of consciousness as self reported 10. History of neurosurgery as self reported

Additional Information

Official title Effects of Transcranial Direct Current Stimulation and Transcranial Ultrasound on the Perception of Pain Due to Osteoarthritis of the Knee
Principal investigator Felipe Fregni, MD, PhD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.