Functional Connectivity & Stimulation-enhanced Therapy Post Stroke

Brain Functional Connectivity & Sensory 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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: task-practice therapy; Other: Vibration

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Hand Motor Function	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.	Baseline to approximately 1 week after the completion of 18 therapy sessions.
Mean Change in Hand Motor Function	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.	Baseline to approximately 4 weeks after the completion of 18 therapy sessions.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Hand Motor Function	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.	Baseline to approximately 1 week after the completion of 18 therapy sessions.
Mean Change in Hand Motor Function	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.	Baseline to approximately 4 weeks after the completion of 18 therapy sessions.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute of General Medical Sciences (NIGMS); University of Delaware
• Investigators: Study Chair: Steve Kautz, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): September 24, 2018
• Study Completion (Actual): September 24, 2018

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Occupational Therapy; Hand Function; Physical Stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PRO74041; U54GM104941 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No