Pilot/Pivotal Study of DBS+Rehab After Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorEnspire DBS Therapy, Inc.
About this trial
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.
Disqualifiers
Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus
Trial design
Design model
Parallel
Treatments tested in this trial
Deep Brain Stimulation
DeviceDeep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
Rehabilitation
Other interventionMotor rehabilitation to improve upper-extremity function.
Treatment groups
202 Participants
are divided into 2 treatment groupsGroup A: DBS+RehabExperimental treatment 1 intervention
Group B: RehabActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct).
Time frame
Week-12 to Week-32Secondary outcomes
1
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
The change in FMA-UE for subjects who receive Test treatment (Tt) is significantly above a clinically important difference (CID)
Time frame
Week-12 to Week-32Other outcomes
1
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
Exploratory endpoints will be examined for the group originally assigned to Control treatment after crossover.
Time frame
Week-32, Week-40 and Week 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov