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Recruiting NCT05701280

Pilot/Pivotal Study of DBS+Rehab After Stroke

No phase Interventional Stroke Upper Extremity Paresis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Brain Stimulation, Rehabilitation.
Who it may be relevant to
Registry conditions: Stroke, Upper Extremity Paresis. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study

Overview

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

Detailed description

The RESTORE Stroke Study combines two phases of study under one protocol (pilot/pivotal). The first phase has a sample size of 40 subjects. The second phase has an estimated sample size of 162 subjects which may be adjusted based on analysis of the first phase.

Each subject will be implanted with the DBS system, undergo DBS program optimization, and be randomized to test treatment (Tt) or active-control treatment (Ct). After randomization, all subjects will participate in a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, subjects assigned to active-control treatment (Ct) will cross over to receive test treatment (Tt) and participate in a second five-month therapy program.

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.

Primary outcome measures

  • Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) [Time frame: Week-12 to Week-32]
Secondary outcome measures (1)
  • Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) [Time frame: Week-12 to Week-32]

Eligibility criteria

Inclusion criteria

  • Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.

Exclusion criteria

  • Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
  • Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 10 centers
  • Barrow Neurological Institute (BNI) — Phoenix
  • Mayo Clinic Florida — Jacksonville
  • Johns Hopkins School of Medicine — Baltimore
  • Massachusetts General Hospital — Boston
  • Mayo Clinic — Rochester
  • NYU Langone Health — New York
  • Cleveland Clinic — Cleveland
  • Thomas Jefferson University — Philadelphia
  • … and 2 more centers

Identifiers

NCT: NCT05701280 · REDD 0084

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗