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Functional Connectivity & Stimulation-enhanced Therapy Post Stroke

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ClinicalTrials.gov Identifier: NCT03473808
Recruitment Status : Completed
First Posted : March 22, 2018
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
National Institute of General Medical Sciences (NIGMS)
University of Delaware
Information provided by (Responsible Party):
Na Jin Seo, Medical University of South Carolina

Brief Summary:
After stroke, it is common for individuals to experience hand impairment. This deficit can severely restrict functional ability and independence. Recovery of hand function following stroke is highly variable. In this study, the investigators will use brain imaging to predict individual response to treatment. Survivors of stroke will receive upper extremity therapy while they concurrently receive imperceptible vibration to the wrist aimed to enhance therapy outcomes.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: task-practice therapy Other: Vibration Not Applicable

Detailed Description:
The ability to predict individuals' responses to treatment can enable effective allocation of a treatment to likely responders. The long-term goal is to determine whether acute changes in brain functional connectivity immediately after one treatment session can predict ultimate gains in motor function after completing multiple treatment sessions. The objective of this study is to determine feasibility and to examine association between change in brain functional connectivity after one session and motor gains after completion of all treatment sessions. This study is a prospective single-cohort longitudinal study. The treatment is task-practice therapy (3d/wk, 18-session) accompanied with concurrent imperceptible wrist vibration that is intended to prime the cortical sensorimotor network and enhance hand functional recovery in chronic stroke survivors. Hand function will be assessed before/after therapy and at 1-month follow-up. Connectivity will be assessed using fMRI and EEG before and after a treatment session.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brain Functional Connectivity & Sensory Stimulation-enhanced Therapy Post Stroke
Actual Study Start Date : March 7, 2018
Actual Primary Completion Date : September 24, 2018
Actual Study Completion Date : September 24, 2018

Arm Intervention/treatment
Experimental: therapy + vibration
Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.
Behavioral: task-practice therapy
Standardized hand therapy program

Other: Vibration
Peripheral vibration applied to the wrist skin at an imperceptible level




Primary Outcome Measures :
  1. Mean Change in Hand Motor Function [ Time Frame: Baseline to approximately 1 week after the completion of 18 therapy sessions. ]
    Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.

  2. Mean Change in Hand Motor Function [ Time Frame: Baseline to approximately 4 weeks after the completion of 18 therapy sessions. ]
    Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.


Secondary Outcome Measures :
  1. Mean Change in Hand Motor Function [ Time Frame: Baseline to approximately 1 week after the completion of 18 therapy sessions. ]
    Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes.

  2. Mean Change in Hand Motor Function [ Time Frame: Baseline to approximately 4 weeks after the completion of 18 therapy sessions. ]
    Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes.



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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:

  • Age = 18 or older
  • At least 6 months post-stroke
  • Moderate upper limb impairment with the ability to participate in hand task practices
  • Fingertip touch sensory deficits (e.g., Monofilament>2.83, 2-point discrimination>5mm, sense of numbness, tingling)

Exclusion Criteria:

  • Complete upper limb deafferentation
  • Rigidity (Modified Ashworth Scale=5)
  • Botulinum toxin injection within 3 months prior to enrollment or during enrollment
  • 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)
  • Concurrent upper extremity rehabilitation therapy
  • Language barrier or cognitive impairment that precludes following instructions or providing consent
  • MRI incompatible.

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): NCT03473808


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Medical University of South Carolina
National Institute of General Medical Sciences (NIGMS)
University of Delaware
Investigators
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Study Chair: Steve Kautz, PhD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Na Jin Seo, Medical University of South Carolina:

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Responsible Party: Na Jin Seo, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03473808     History of Changes
Other Study ID Numbers: PRO74041
U54GM104941 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2018    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Na Jin Seo, Medical University of South Carolina:
Hand Function
Occupational Therapy
Physical Stimulation

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