Functional Connectivity & Stimulation-enhanced Therapy Post Stroke

Stroke Clinical Trial

Official title:

Brain Functional Connectivity & Sensory Stimulation-enhanced Therapy Post Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03473808
• Other study ID #: PRO74041
• Secondary ID: U54GM104941
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: September 24, 2018

Study information

• Verified date: March 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 24, 2018
• Est. primary completion date: September 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• task-practice therapy
Standardized hand therapy program

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of General Medical Sciences (NIGMS), University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.