RECRUITING

Pilot/Pivotal Study of DBS+Rehab After Stroke

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.

Official Title

Rehab with Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): a Pivotal Study

Quick Facts

Study Start:2023-02-03
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05701280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.
  1. * Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
  2. * Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus

Contacts and Locations

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55906
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Enspire DBS Therapy, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-03
Study Completion Date2030-06

Study Record Updates

Study Start Date2023-02-03
Study Completion Date2030-06

Terms related to this study

Keywords Provided by Researchers

  • Ischemic Stroke
  • Deep Brain Stimulation
  • DBS
  • Physical Therapy
  • Rehabilitation
  • Brain Stimulation

Additional Relevant MeSH Terms

  • Stroke
  • Upper Extremity Paresis