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Completed

NCT Number: NCT03473808

Functional Connectivity & Stimulation-enhanced Therapy Post Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

task-practice therapy

Behavioral

Standardized hand therapy program

Vibration

Other

Peripheral vibration applied to the wrist skin at an imperceptible level

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)
  • University of Delaware

Registry information

Official study title

Brain Functional Connectivity & Sensory Stimulation-enhanced Therapy Post Stroke

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2018
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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