Clinical trial NCT03473808: Functional Connectivity & Stimulation-enhanced Therapy Post Stroke
Official title: Brain Functional Connectivity & Sensory Stimulation-enhanced Therapy Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hand Function
Occupational Therapy
Physical Stimulation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: University of Delaware
First posted: 2018-03-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Mean Change in Hand Motor Function
timeFrame: Baseline to approximately 1 week after the completion of 18 therapy sessions.
measure: Mean Change in Hand Motor Function
timeFrame: Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
Secondary outcomes:
measure: Mean Change in Hand Motor Function
timeFrame: Baseline to approximately 1 week after the completion of 18 therapy sessions.
measure: Mean Change in Hand Motor Function
timeFrame: Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Steve Kautz, PhD
role: STUDY_CHAIR
References: