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Pilot/Pivotal Study of DBS+Rehab After Stroke

NCT05701280 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2026-01-21

No results posted yet for this study

Summary

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

Conditions

  • Stroke
  • Upper Extremity Paresis

Interventions

DEVICE

Deep Brain Stimulation

Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.

OTHER

Rehabilitation

Motor rehabilitation to improve upper-extremity function.

Sponsors & Collaborators

  • Enspire DBS Therapy, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2026-06-30
Completion
2030-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701280 on ClinicalTrials.gov