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Effects of tDCS and tUS on Pain Perception in OA of the Knee

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ClinicalTrials.gov Identifier: NCT02330315
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
Highland Instruments, Inc.
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Osteoarthritis Device: transcranial direct current stimulation (tDCS) Device: transcranial ultrasound (TUS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) on the Perception of Pain and Functional Limitations Due to Osteoarthritis of the Knee.
Study Start Date : March 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS + Active TUS
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)
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.

Device: transcranial ultrasound (TUS)
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.

Sham Comparator: Sham tDCS + Sham 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)
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.

Device: transcranial ultrasound (TUS)
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.




Primary Outcome Measures :
  1. Changes in Pain Scale [ Time Frame: Measured for approximately 2 months ]
    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).


Secondary Outcome Measures :
  1. Changes in Mood [ Time Frame: Measured for approximately 2 months ]
    The investigators will measure safety of tDCS and TUS by measuring changes in the Visual Analog Mood Scale (VAMS).

  2. Changes in cognition, attention, and focus [ Time Frame: Measured for approximately 2 months ]
    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.

  3. Adverse Events [ Time Frame: Measured for approximately 2 months ]
    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.

  4. Physical Examinations [ Time Frame: Measured for approximately 2 months ]
    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.

  5. Single Leg Standing Balance Test [ Time Frame: Measured for approximately 2 months ]
    The investigators will measure how long the subject can stand on one foot in order to measure any changes in balance

  6. Knee Proprioceptive Test [ Time Frame: Measured for approximately 2 months ]
    Proprioceptive acuity will be assessed by the ability to reproduce passive positioning of the leg with eyes closed.

  7. Knee Extensor/Flexor Force Test [ Time Frame: Measured for approximately 2 months ]
    The investigators will measure whether there are changes in knee extension/flexion abilities.

  8. Knee Range of Motion (ROM) [ Time Frame: Measured for approximately 2 months ]
    The knee range of motion (flexion/extension angle) will be recorded with an electrogoniometer and motion analysis capture system.

  9. Step Test [ Time Frame: Measured for approximately 2 months ]
    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.

  10. Functional Reach Test [ Time Frame: Measured for approximately 2 months ]
    The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study.

  11. Timed Up and Go Test [ Time Frame: Measured for approximately 2 months ]
    The investigators will measure if there are changes in the walking speed of the subject from the beginning of the study to the end.

  12. Changes in quality of life [ Time Frame: Measured for approximately 2 months ]
    The investigators will use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in quality of life and physical functioning.

  13. Neurological Examinations [ Time Frame: Measured for approximately 2 months ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to provide informed consent to participate in the study.
  2. Subjects between 18-85 years old.
  3. 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.

  4. Existing knee pain in the past 6 months of at least 3 on a 0-10 VAS scale on average.
  5. Pain resistant to common analgesics and medications for chronic pain used as initial pain management such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
  6. Having the ability to feel pain as self-reported

Exclusion Criteria:

  1. Pregnancy or trying to become pregnant in the next 6 months.
  2. History of alcohol or drug abuse within the past 6 months as self-reported.
  3. Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain medical devices or implanted brain metallic devices.
  4. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
  5. Epilepsy.
  6. Use of carbamazepine within the past 6 months as self-reported.
  7. Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)
  8. History of unexplained fainting spells as self-reported.
  9. Head injury resulting in more than a momentary loss of consciousness
  10. History of neurosurgery as self-reported.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330315


Locations
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United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Highland Instruments, Inc.
Investigators
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Principal Investigator: Timothy Wagner, PhD Highland Instruments, Inc.

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Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02330315     History of Changes
Other Study ID Numbers: 2014P002496
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
transcranial direct current stimulation
transcranial ultrasound
non-invasive brain stimulation

Additional relevant MeSH terms:
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Osteoarthritis
Chronic Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms