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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week-32, week-40 and week 52
Awards & highlights
RESTORE Trial 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.Check my eligibility
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.See study design
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.
RESTORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stroke 1-6 years ago and still have weakness in one arm.
RESTORE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week-32, week-40 and week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week-32, week-40 and week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Other outcome measures
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
Side effects data
From 2018 Phase 2 trial • 53 Patients • NCT0122194823%
Fall
15%
Depression
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Head injury
5%
Dyspepsia
5%
Back pain
5%
Speech disorder
5%
Skeletal injury
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Pain in extremity
3%
Diabetes mellitus
3%
Intervertebral disc protrusion
3%
Spinal osteoarthritis
3%
Fluid retention
3%
Postoperative wound infection
3%
Osteoarthritis
3%
Macular degeneration
3%
Hypoaesthesia
3%
Ingrowing nail
3%
Respiratory depression
3%
Parkinson's disease
3%
Akinesia
3%
Productive cough
3%
Device migration
3%
Syncope
3%
Diplopia
3%
Skin laceration
3%
Joint sprain
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Alcohol poisoning
3%
Contusion
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
RESTORE 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
~700
Find a Location
Who is running the clinical trial?
Enspire DBS Therapy, Inc.Lead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stroke 1-6 years ago and still have weakness in one arm.My brain cancer affects critical areas like the brainstem.I have had a stroke that affected my arm's movement.
Research Study Groups:
This trial has the following groups:- Group 1: Rehab
- Group 2: DBS+Rehab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open to this research endeavor?
"Affirmative. According to the information present on clinicaltrials.gov, this research is actively seeking participants since it was initially posted on March 1st 2023 and most recently amended on 17th of that same month. The study aims to enrol 202 patients in a single medical facility."
Answered by AI
How many individuals are participating in this trial?
"Right, according to the information accessible on clinicaltrials.gov this medical investigation is still searching for participants. It was initially published on March 1st 2023 and its details were last updated 17 days later. 202 individuals are being sought out from a single site."
Answered by AI
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