An interventional study of transcranial direct current stimulation (tDCS) and transcranial ultrasound (TUS) in Chronic Pain and Osteoarthritis, sponsored by Spaulding Rehabilitation Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and functional limitations in people 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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 28 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Spaulding Rehabilitation Hospital is the lead sponsor of 114 studies on the registry; 26 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
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Diagnosis of chronic osteoarthritis with pain of either the knee as self-reported.
Prior to beginning baseline procedures this must be confirmed by medical records or a letter from the subject's physician. This document may either be brought in by the subject or retrieved by study staff after a medical release form is signed by the subject. After consent, if the subject fails to provide the necessary documentation or it cannot be retrieved by study staff the subject will be considered a screen fail.
Exclusion Criteria:
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Device: transcranial direct current stimulation (tDCS) · Device: transcranial ultrasound (TUS)
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Device: transcranial direct current stimulation (tDCS) · Device: transcranial ultrasound (TUS)
Subjects will receive 20 minutes of either active or sham tDCS at 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. In the sham group, the tDCS device will not be active for the full 20 minutes.
Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
Changes in Pain Scale
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to 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 osteoarthritis knee pain. The investigators will also look at changes in the Von Frey assessment and pain pressure threshold (PPT).
Time frame: Measured for approximately 2 months
Changes in Mood
The investigators will measure safety of tDCS and TUS by measuring changes in the Visual Analog Mood Scale (VAMS).
Time frame: Measured for approximately 2 months
Changes in cognition, attention, and focus
The investigators will monitor the safety of tDCS and TUS in subjects by measuring any changes in cognition, attention, and focus with the California Computerized Assessment Package (CalCap) mini.
Time frame: Measured for approximately 2 months
Adverse Events
At each session, subjects will complete a questionnaire to evaluate potential adverse effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale. The scale will also be administered at the follow-ups.
Time frame: Measured for approximately 2 months
Physical Examinations
Trained study staff will perform standard physical examinations at several points throughout the study to ensure subject safety. Baseline findings will be compared to the findings observed at the various time points throughout the study to ensure there are no significant changes that may be study related.
Time frame: Measured for approximately 2 months
Single Leg Standing Balance Test
The investigators will measure how long the subject can stand on one foot in order to measure any changes in balance
Time frame: Measured for approximately 2 months
Knee Proprioceptive Test
Proprioceptive acuity will be assessed by the ability to reproduce passive positioning of the leg with eyes closed.
Time frame: Measured for approximately 2 months
Knee Extensor/Flexor Force Test
The investigators will measure whether there are changes in knee extension/flexion abilities.
Time frame: Measured for approximately 2 months
Knee Range of Motion (ROM)
The knee range of motion (flexion/extension angle) will be recorded with an electrogoniometer and motion analysis capture system.
Time frame: Measured for approximately 2 months
Step Test
Subject will be asked to stand unsupported with the feet parallel to each other and a block 5 cm directly in front of them. Subject will then be advised which leg is the stepping leg and asked to place the whole foot onto the block, then return it fully down to the floor. This procedure will be repeated as fast as possible.
Time frame: Measured for approximately 2 months
Functional Reach Test
The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study.
Time frame: Measured for approximately 2 months
Timed Up and Go Test
The investigators will measure if there are changes in the walking speed of the subject from the beginning of the study to the end.
Time frame: Measured for approximately 2 months
Changes in quality of life
The investigators will use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in quality of life and physical functioning.
Time frame: Measured for approximately 2 months
Neurological Examinations
Trained study staff will perform standard neurological examinations at several points throughout the study to ensure subject safety. Baseline findings will be compared to the findings observed at the various time points throughout the study to ensure there are no significant changes that may be study related.
Time frame: Measured for approximately 2 months
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Spaulding Rehabilitation Hospital