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Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke

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ClinicalTrials.gov Identifier: NCT04026399
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. While promising, most modalities of sensory stimulation interfere with natural hand tasks. To address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. In this study, we will determine if use of this vibration increases hand functional recovery.

Condition or disease Intervention/treatment Phase
Stroke Physical Disability Other: peripheral vibration stimulation Behavioral: therapy Not Applicable

Detailed Description:
The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. Follow-up evaluation will occur 3 months after. The device will deliver vibration (treatment) or no vibration (control).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Arm Intervention/treatment
Experimental: stimulation + therapy
The participant receives stimulation and home therapy.
Other: peripheral vibration stimulation
wearing a wristband that delivers imperceptible vibratory stimulation.

Behavioral: therapy
practice of daily living tasks

Sham Comparator: no stimulation + therapy
The participant receives no stimulation and receives home therapy.
Behavioral: therapy
practice of daily living tasks




Primary Outcome Measures :
  1. short-latency afferent inhibition [ Time Frame: 1 month ]
    motor evoked potential suppression by conditioning electrical stimulation


Secondary Outcome Measures :
  1. Box and Block Test [ Time Frame: 1 month ]
    number of blocks moved in a minute

  2. Wolf Motor Function Test [ Time Frame: 1 month ]
    standardized clinical upper extremity function score

  3. Action Research Arm Test [ Time Frame: 1 month ]
    standardized clinical upper extremity function score


Other Outcome Measures:
  1. Stoke Impact Scale hand subscale [ Time Frame: 1 month ]
    standardized patient-reported hand function assessment

  2. Stoke Impact Scale hand subscale [ Time Frame: 4 month ]
    standardized patient-reported hand function assessment

  3. timing of reactive force generation per perturbation [ Time Frame: 1 month ]
    time of reactive force

  4. timing of reactive force generation per perturbation [ Time Frame: 4 month ]
    time of reactive force

  5. Fugl-Meyer upper limb assessment [ Time Frame: 1 month ]
    standardized clinical upper extremity function score

  6. Fugl-Meyer upper limb assessment [ Time Frame: 4 month ]
    standardized clinical upper extremity function score

  7. grip force direction [ Time Frame: 1 month ]
    angle of the grip force vector from the normal direction

  8. grip force direction [ Time Frame: 4 month ]
    angle of the grip force vector from the normal direction

  9. in-home hand use amount [ Time Frame: 1 month ]
    affected hand use amount as measured by accelerometers

  10. in-home hand use amount [ Time Frame: 4 month ]
    affected hand use amount as measured by accelerometers

  11. reactive force magnitude per perturbation [ Time Frame: 1 month ]
    magnitude of reactive grip force

  12. reactive force magnitude per perturbation [ Time Frame: 4 month ]
    magnitude of reactive grip force

  13. safety margin [ Time Frame: 1 month ]
    additional force used during grip

  14. safety margin [ Time Frame: 4 month ]
    additional force used during grip

  15. corticomotor excitability [ Time Frame: 1 month ]
    motor evoked potential amplitude

  16. corticomotor excitability [ Time Frame: 4 month ]
    motor evoked potential amplitude

  17. spectral power perturbation during grip [ Time Frame: 1 month ]
    EEG spectral power perturbation during grip

  18. spectral power perturbation during grip [ Time Frame: 4 month ]
    EEG spectral power perturbation during grip

  19. connectivity [ Time Frame: 1 month ]
    EEG coherence within the sensorimotor network

  20. connectivity [ Time Frame: 4 month ]
    EEG coherence within the sensorimotor network

  21. short-latency afferent inhibition [ Time Frame: 4 month ]
    motor evoked potential suppression by conditioning electrical stimulation

  22. Box and Block Test [ Time Frame: 4 month ]
    number of blocks moved in a minute

  23. Wolf Motor Function Test [ Time Frame: 4 month ]
    standardized clinical upper extremity function score

  24. Action Research Arm Test [ Time Frame: 4 month ]
    standardized clinical upper extremity function score



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Chronic stroke survivor (>= 6 months post stroke)
  • Ability to move an object with the paretic hand
  • Fingertip sensory deficits
  • Ability to put on a watch daily (by oneself or with help)

Exclusion Criteria:

  • Currently undergoing other upper extremity rehabilitation therapy
  • Upper limb botulinum toxin within 3 months prior to or during enrollment
  • Change in neurological disorder medications during the enrollment
  • Complete upper limb deafferentation
  • Rigidity (Modified Ashworth Scale=5)
  • Brainstem stroke
  • Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
  • Language barrier or cognitive impairment that precludes following instructions and/or providing consent

If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.


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): NCT04026399


Contacts
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Contact: Na Jin Seo, PhD 8437920084 seon@musc.edu

Locations
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United States, South Carolina
Medical University of South Caorlina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Andrew Fortune, BS    843-792-8970    fortunea@musc.edu   
Principal Investigator: Na Jin Seo, PhD         
Sponsors and Collaborators
Medical University of South Carolina
National Institute of General Medical Sciences (NIGMS)
Investigators
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Study Chair: Steven Kautz, PhD Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04026399     History of Changes
Other Study ID Numbers: Pro00086207
P20GM109040 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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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 Medical University of South Carolina:
physical stimulation
Subliminal stimulation
stroke rehabilitation
upper extremity
paresis
hand function
occupational therapy
physical therapy

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases