Functional Connectivity & Stimulation-enhanced Therapy Post Stroke

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2018-09-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sensory Stimulation to Enhance Hand Function Post Stroke

NCT02675764

Stroke

COMPLETED NA

Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke

NCT04569123

Stroke Physical Disability

COMPLETED NA

Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke

NCT04026399

Stroke Physical Disability

COMPLETED NA

Brain-behavior Associations of Sensorimotor Therapy Post Stroke

NCT03236376

Stroke

COMPLETED NA

Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

NCT03067818

Stroke Hemiparesis Cerebral Vascular Accident +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

therapy + vibration

Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.

Group Type EXPERIMENTAL

task-practice therapy

Intervention Type BEHAVIORAL

Standardized hand therapy program

Vibration

Intervention Type OTHER

Peripheral vibration applied to the wrist skin at an imperceptible level

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

task-practice therapy

Standardized hand therapy program

Intervention Type BEHAVIORAL

Vibration

Peripheral vibration applied to the wrist skin at an imperceptible level

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No