Deep Brain Stimulation + Rehab for Stroke-related Arm Weakness
(RESTORE Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Enspire DBS Therapy, Inc.
Disqualifiers: Cerebrovascular events, Brain lesions, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Deep Brain Stimulation + Rehab for Stroke-related Arm Weakness?
Research shows that combining different types of electrical stimulation and robotic therapy can improve arm function in stroke patients. For example, studies have found that functional electrical stimulation and robotic-assisted therapy can help stroke survivors regain arm movement and control. While these studies don't directly involve deep brain stimulation, they suggest that combining brain and physical therapies can be beneficial for stroke recovery.
12345Is Deep Brain Stimulation safe for treating stroke-related arm weakness?
While the specific safety data for Deep Brain Stimulation (DBS) in treating stroke-related arm weakness is not provided, similar treatments like vagus nerve stimulation paired with rehabilitation have been studied. These studies show that while there can be serious adverse events related to surgery, the treatment is generally well-tolerated and has been used safely in humans for improving arm function after stroke.
678910How is Deep Brain Stimulation (DBS) different from other treatments for stroke-related arm weakness?
Deep Brain Stimulation (DBS) is unique because it involves implanting electrodes in the brain to directly stimulate specific areas, which can enhance brain plasticity and improve motor function. This is different from other treatments like transcranial magnetic stimulation or vagus nerve stimulation, which are non-invasive and work by stimulating the brain or nerves from outside the body.
911121314Eligibility Criteria
This trial is for individuals who had an ischemic stroke between 1 and 6 years ago, leading to ongoing weakness in one arm. It's not suitable for those with additional strokes affecting the arm or significant damage to certain brain areas like the brainstem, cerebellum, or thalamus.Inclusion Criteria
I had a stroke 1-6 years ago and still have weakness in one arm.
Exclusion Criteria
My brain cancer affects critical areas like the brainstem.
I have had a stroke that affected my arm's movement.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Implantation and Optimization
Each subject will be implanted with the DBS system and undergo DBS program optimization
4 weeks
Randomized Treatment
Subjects are randomized to test treatment or active-control treatment and participate in a five-month outpatient rehabilitation therapy program
20 weeks
Crossover Treatment
Subjects assigned to active-control treatment cross over to receive test treatment and participate in a second five-month therapy program
20 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Participant Groups
The RESTORE Stroke Study is testing whether combining Deep Brain Stimulation (DBS) with rehabilitation therapy can improve arm strength and function after a stroke.
2Treatment groups
Experimental Treatment
Active Control
Group I: DBS+RehabExperimental Treatment1 Intervention
Active-DBS combined with motor rehabilitation
Group II: RehabActive Control1 Intervention
Control-DBS combined with motor rehabilitation
Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Stroke-related motor deficits (under investigation)
🇪🇺 Approved in European Union as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
🇨🇦 Approved in Canada as Deep Brain Stimulation for:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicRochester, MN
Rhode Island HospitalProvidence, RI
Medical University of South Carolina (MUSC)Charleston, SC
Massachusetts General HospitalBoston, MA
More Trial Locations
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Who Is Running the Clinical Trial?
Enspire DBS Therapy, Inc.Lead Sponsor
References
Deep repetitive transcranial magnetic stimulation with H-coil on lower limb motor function in chronic stroke: a pilot study. [2016]To assess the efficacy of high-frequency (20 Hz) brain stimulation on lower limb motor function in subjects with chronic (> 6 mo) subcortical stroke.
Effects of a Robot-Assisted Arm Training Plus Hand Functional Electrical Stimulation on Recovery After Stroke: A Randomized Clinical Trial. [2020]To compare the effects of unilateral, proximal arm robot-assisted therapy combined with hand functional electrical stimulation with intensive conventional therapy for restoring arm function in survivors of subacute stroke.
Efficacy of Four-Channel Functional Electrical Stimulation on Moderate Arm Paresis in Subacute Stroke Patients-Results from a Randomized Controlled Trial. [2022]This preliminary randomized clinical trial explores the efficacy of task-oriented electromyography (EMG)-triggered multichannel functional electrical stimulation (EMG-MES) compared to single-channel cyclic neuromuscular electrical stimulation (cNMES) on regaining control of voluntary movements (CVM) and the ability to execute arm-hand-activities in subacute stroke patients with moderate arm paresis. Twelve ischemic stroke patients (Fugl-Meyer Assessment Arm Section (FMA-AS) score: 19-47) with comparable demographics were block-randomized to receive 15 sessions of cNMES or EMG-MES over three weeks additionally to a conventional neurorehabilitation program including task-oriented arm training. FMA-AS, Box-and-Block Test (BBT), and Stroke-Impact-Scale (SIS) were recorded at baseline and follow-up. All participants demonstrated significant improvement in FMA-AS and BBT. Participants treated with EMG-MES had a higher mean gain in FMA-AS than those treated with cNMES. In the SIS daily activities domain, both groups improved non-significantly; participants in the EMG-MES group had higher improvement in arm-hand use and stroke recovery. EMG-MES treatment demonstrated a higher gain of CVM and self-reported daily activities, arm-hand use, and stroke recovery compared to cNMES treatment of the wrist only. The protocol of this proof-of-concept study seems robust enough to be used in a larger trial to confirm these preliminary findings.
Electrical stimulation of the upper limb in stroke: stimulation of the extensors of the hand vs. alternate stimulation of flexors and extensors. [2019]To investigate whether there is a difference in functional improvement in the affected arm of chronic stroke patients when comparing two methods of electrical stimulation.
Combined transcranial direct current stimulation and robotic upper limb therapy improves upper limb function in an adult with cerebral palsy. [2018]Robotic therapy can improve upper limb function in hemiparesis. Excitatory transcranial direct current stimulation (tDCS) can prime brain motor circuits before therapy.
Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. [2019]Background and Purpose- We assessed safety, feasibility, and potential effects of vagus nerve stimulation (VNS) paired with rehabilitation for improving arm function after chronic stroke. Methods- We performed a randomized, multisite, double-blinded, sham-controlled pilot study. All participants were implanted with a VNS device and received 6-week in-clinic rehabilitation followed by a home exercise program. Randomization was to active VNS (n=8) or control VNS (n=9) paired with rehabilitation. Outcomes were assessed at days 1, 30, and 90 post-completion of in-clinic therapy. Results- All participants completed the course of therapy. There were 3 serious adverse events related to surgery. Average FMA-UE scores increased 7.6 with active VNS and 5.3 points with control at day 1 post-in-clinic therapy (difference, 2.3 points; CI, -1.8 to 6.4; P=0.20). At day 90, mean scores increased 9.5 points from baseline with active VNS, and the control scores improved by 3.8 (difference, 5.7 points; CI, -1.4 to 11.5; P=0.055). The clinically meaningful response rate of FMA-UE at day 90 was 88% with active VNS and 33% with control VNS ( P
Vagus Nerve Stimulation Paired With Rehabilitation for Upper Limb Motor Impairment and Function After Chronic Ischemic Stroke: Subgroup Analysis of the Randomized, Blinded, Pivotal, VNS-REHAB Device Trial. [2023]Vagus Nerve Stimulation (VNS) paired with rehabilitation improved upper extremity impairment and function in a recent pivotal, randomized, triple-blind, sham-controlled trial in people with chronic arm weakness after stroke.
Fully Implantable Peripheral Nerve Stimulation for Hemiplegic Shoulder Pain: A Multi-Site Case Series With Two-Year Follow-Up. [2022]To explore the feasibility and safety of a single-lead, fully implantable peripheral nerve stimulation system for the treatment of chronic shoulder pain in stroke survivors.
Paired vagus nerve stimulation for treatment of upper extremity impairment after stroke. [2022]The use of a paired vagus nerve stimulation (VNS) system for the treatment of moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke has recently been approved by the US Food and Drug Administration. This treatment aims to increase the task-specific neuroplasticity through the activation of cholinergic and noradrenergic networks during rehabilitation therapy. A recent pivotal Phase III trial showed that VNS paired with rehabilitation led to improvements in upper extremity impairment and function in people with moderate-to-severe arm weakness for an average of 3 years after ischemic stroke. The between-group difference following 6 weeks of in-clinic therapy and 90 days of home exercise therapy was three points on the upper extremity Fugl-Meyer score. A clinically meaningful response defined as a greater than or equal to six-point improvement was seen in approximately half of the people treated with VNS compared to approximately a quarter of people treated with rehabilitation alone. Further post-marketing research should aim to establish whether the treatment is also of use for people with intracerebral hemorrhage, in people with more severe arm weakness, and for other post-stroke impairments. In addition, high-quality randomized studies of non-invasive VNS are required.
Electrical stimulation for treating chronic poststroke shoulder pain using a fully implanted microstimulator with internal battery. [2016]This case report describes the first stroke survivor with chronic poststroke shoulder pain treated with electrical stimulation delivered via a fully implanted microstimulator containing a rechargeable internal battery. In light of existing efficacy data for similar types of treatment, the investigational system described in this report was developed to address the limitations of previously evaluated electrical stimulation devices. A 58-yr-old male stroke survivor with chronic hemiparesis and chronic shoulder pain received up to 6 hrs of stimulation daily over 12 wks. The microstimulator was implanted percutaneously near the axillary nerve at the quadrilateral space, under local anesthesia during an outpatient procedure. The implantation procedure was well tolerated. There were no adverse events related to the implantation procedure or treatment (implanted peripheral nerve stimulation). Outcomes were obtained before treatment, after 12 wks of treatment, and at 3-mo follow-up. Question no. 12 of the Brief Pain Inventory was used as the primary outcome measure to evaluate response to treatment. Shoulder pain decreased from 8/10 before treatment to 4/10 after treatment and decreased further to 3/10 at 3-mo follow-up. Passive range of motion and motor function also improved after treatment. Sensation, shoulder subluxation, activities, and quality-of-life did not change. The feasibility, safety, and efficacy of implanted peripheral nerve stimulation to treat poststroke shoulder pain should be evaluated further in clinical trials already underway.
The effects of electromyography-triggered electrical stimulation on shoulder subluxation, muscle activation, pain, and function in persons with stroke: A pilot study. [2018]The purpose of this study was to examine the effects of task-oriented electromyography-triggered stimulation for shoulder subluxation, muscle activation, pain and upper extremity function in hemiparetic stroke patients.
New modalities of brain stimulation for stroke rehabilitation. [2021]Stroke is a leading cause of disability, and the number of stroke survivors continues to rise. Traditional neurorehabilitation strategies aimed at restoring function to weakened limbs provide only modest benefit. New brain stimulation techniques designed to augment traditional neurorehabilitation hold promise for reducing the burden of stroke-related disability. Investigators discovered that repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), and epidural cortical stimulation (ECS) can enhance neural plasticity in the motor cortex post-stroke. Improved outcomes may be obtained with activity-dependent stimulation, in which brain stimulation is contingent on neural or muscular activity during normal behavior. We review the evidence for improved motor function in stroke patients treated with rTMS, tDCS, and ECS and discuss the mediating physiological mechanisms. We compare these techniques to activity-dependent stimulation, discuss the advantages of this newer strategy for stroke rehabilitation, and suggest future applications for activity-dependent brain stimulation.
Non-invasive cerebral stimulation for the upper limb rehabilitation after stroke: a review. [2016]Numerous studies have recently been published on improving upper-limb motor function after stroke. There has been a particular interest in brain stimulation techniques, which could promote brain plasticity. In this review, transcranial Direct Current Stimulation (tDCS) and repetitive Transcranial Magnetic Stimulation (rTMS) are presented as techniques that could be relevant in Physical Medicine and Rehabilitation (PM&R) centers in the future. We are presenting a comprehensive literature review on the studies using tDCS or rTMS for upper-limb rehabilitation after a stroke. Both techniques have shown their ability to modify cortical excitability and to transitorily improve upper-limb function after one single stimulation session. The first placebo-controlled, blinded therapeutic trials, which included repeated daily sessions, seem quite promising, and deserve to be validated by further trials.
Multiple sessions of transcranial direct current stimulation and upper extremity rehabilitation in stroke: A review and meta-analysis. [2022]To systematically review the methodology in particular treatment options and outcomes and the effect of multiple sessions of transcranial direct current stimulation (tDCS) with rehabilitation programmes for upper extremity recovery post stroke.