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

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ClinicalTrials.gov Identifier: NCT02723929
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : October 25, 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: active low-intensity transcranial electrical stimulation/active transcranial ultrasound Device: Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: tDCS and tUS
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 : September 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Electrical Stim/Active Ultrasound
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Device: active low-intensity transcranial electrical stimulation/active transcranial ultrasound

Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for the full 20 minutes.

Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.


Sham Comparator: Sham Electrical Stim/Sham Ultrasound
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Device: Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound

Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.

Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.





Primary Outcome Measures :
  1. Changes in Pain Scale as measured by VAS [ 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.


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

  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 & MMSE

  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. 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

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. Electroencephalography [ Time Frame: Measured for approximately 2 months ]
    Investigators will measure electroencephalogram activity to monitor safety and correlates with pain throughout the study. Baseline recordings will be reviewed to ensure that there are no potential electroencephalographic safety criteria prior to stimulation.

  13. Changes Pain Pressure Threshold (PPT) [ Time Frame: Measured for approximately 2 months ]
    Changes in the pain pressure threshold 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 increasing the pain pressure threshold in subjects with osteoarthritis knee pain.

  14. Changes in mechanical detection threshold as measured through Von-Frey monofilaments [ Time Frame: Measured for approximately 2 months ]
    Changes in the mechanical detection threshold (MDT) will be measured through calibrated Von-Frey monofilaments in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in increasing the mechanical detection threshold of subjects with osteoarthritis knee pain.

  15. Changes in mechanical pain threshold as measured through Von-Frey monofilaments [ Time Frame: Measured for approximately 2 months ]
    Changes in the mechanical pain threshold (MDT) will be measured through calibrated Von-Frey monofilaments in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in increasing the mechanical pain threshold of subjects with osteoarthritis knee pain.

  16. Descending Noxious Inhibitory Control (DNIC) [ Time Frame: Measured for approximately 2 months ]
    Measure of endogenous pain control



Information from the National Library of Medicine

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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 knee as self-reported.
  4. Existing knee pain of at least 3 on a 0-10 VAS scale on average over the past 6 months.
  5. Pain of at least 3 on a 0-10 VAS scale on average over the week prior to the first stimulation session.
  6. 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.
  7. 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): NCT02723929


Contacts
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Contact: Felipe Fregni, MD PhD MPH 617-952-6156 ffregni@partners.org
Contact: Haley E Rafferty, BS 617-952-6158 hrafferty@partners.org

Locations
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United States, Massachusetts
Spaulding Rehabilitation Network Research Institute Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Felipe Fregni, MD PhD MPH    617-952-6156    ffregni@partners.org   
Contact: Haley E Rafferty, BS    617-952-6158    hrafferty@partners.org   
Principal Investigator: Felipe Fregni, MD PhD MPH         
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Highland Instruments, Inc.
Investigators
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Principal Investigator: Felipe Fregni, MD PhD MPH Spaulding Rehabilitation Network

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Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02723929     History of Changes
Other Study ID Numbers: 2016P000486
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

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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