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Deep Brain Stimulation

Deep Brain Stimulation + Rehab for Stroke-related Arm Weakness (RESTORE Trial)

N/A
Recruiting
Research Sponsored by Enspire DBS Therapy, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.
Be older than 18 years old
Must not have
Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus
Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week-32, week-40 and week 52
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a therapy combining deep brain stimulation & rehab can improve arm weakness or reduced function after stroke.

Who is the study for?
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.
What is being tested?
The RESTORE Stroke Study is testing whether combining Deep Brain Stimulation (DBS) with rehabilitation therapy can improve arm strength and function after a stroke.
What are the potential side effects?
Potential side effects of DBS may include headache, confusion, speech problems, balance issues, tingling sensations in the limbs, and mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a stroke 1-6 years ago and still have weakness in one arm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My brain cancer affects critical areas like the brainstem.
Select...
I have had a stroke that affected my arm's movement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week-32, week-40 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week-32, week-40 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)

Side effects data

From 2018 Phase 2 trial • 53 Patients • NCT01221948
23%
Fall
15%
Depression
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Dyspepsia
5%
Back pain
5%
Skeletal injury
5%
Head injury
5%
Speech disorder
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Osteoarthritis
3%
Ingrowing nail
3%
Postoperative wound infection
3%
Diabetes mellitus
3%
Pain in extremity
3%
Spinal osteoarthritis
3%
Alcohol poisoning
3%
Intervertebral disc protrusion
3%
Hypoaesthesia
3%
Diplopia
3%
Contusion
3%
Productive cough
3%
Joint sprain
3%
Macular degeneration
3%
Fluid retention
3%
Device migration
3%
Skin laceration
3%
Akinesia
3%
Parkinson's disease
3%
Syncope
3%
Respiratory depression
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Cerebral microangiopathy
3%
Dysarthria
3%
Memory impairment
3%
Movement disorder
3%
Monarthritis
3%
Neck pain
3%
Adverse drug reaction
3%
Cyst
3%
Implant site haematoma
3%
Oedema peripheral
3%
Pyrexia
3%
Pleural effusion
3%
Nerve root lesion
3%
Anxiety
3%
Cough
3%
Fibula fracture
3%
Thermal burn
3%
Sciatica
3%
Anger
3%
Bursitis
3%
Cystitis
3%
Helicobacter gastritis
3%
Implant site infection
3%
Localised infection
3%
Pneumonia
3%
Staphylococcal infection
3%
Confusional state
3%
Depressed mood
3%
Hallucination, auditory
3%
Impulse-control disorder
3%
Insomnia
3%
Panic attack
3%
Rapid eye movements sleep abnormal
3%
Bronchitis
3%
Ear infection
3%
Incision site infection
3%
Arthralgia
3%
Axillary pain
3%
Folate deficiency
3%
Hypertension
3%
Hypotension
3%
Thrombophlebitis
3%
Laboratory test abnormal
3%
Weight increased
3%
Pericardial effusion
3%
Seborrhoeic keratosis
3%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Deep Brain Stimulation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~710

Find a Location

Who is running the clinical trial?

Enspire DBS Therapy, Inc.Lead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Stroke
12 Patients Enrolled for Stroke

Media Library

Deep Brain Stimulation (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05701280 — N/A
Stroke Research Study Groups: Rehab, DBS+Rehab
Stroke Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT05701280 — N/A
Deep Brain Stimulation (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05701280 — N/A
~45 spots leftby Jun 2025
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