← Back to Search

Deep Brain Stimulation

Deep Brain Stimulation for Stroke (EDEN Trial)

N/A

Waitlist Available

Led By Andre Machado, MD, PhD

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

EDEN Trial Summary

This trial will evaluate if Deep Brain Stimulation is safe for treating stroke and if it improves motor recovery.

Eligible Conditions

Stroke

EDEN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Side effects data

From 2018 Phase 2 trial • 53 Patients • NCT01221948

23%

Fall

15%

Depression

Hand fracture

Restless legs syndrome

Apathy

Head injury

Dyspepsia

Back pain

Speech disorder

Skeletal injury

Tremor

Gait disturbance

Dystonia

Paraesthesia

Influenza

Urinary tract infection

Pain in extremity

Diabetes mellitus

Intervertebral disc protrusion

Spinal osteoarthritis

Fluid retention

Postoperative wound infection

Osteoarthritis

Macular degeneration

Hypoaesthesia

Ingrowing nail

Respiratory depression

Parkinson's disease

Akinesia

Productive cough

Device migration

Syncope

Diplopia

Skin laceration

Joint sprain

Rib fracture

Drug withdrawal syndrome

Alcohol poisoning

Contusion

Cerebral microangiopathy

Dysarthria

Memory impairment

Movement disorder

Monarthritis

Neck pain

Adverse drug reaction

Cyst

Implant site haematoma

Oedema peripheral

Pyrexia

Pleural effusion

Nerve root lesion

Anxiety

Cough

Fibula fracture

Thermal burn

Sciatica

Anger

Bursitis

Cystitis

Helicobacter gastritis

Implant site infection

Localised infection

Pneumonia

Staphylococcal infection

Confusional state

Depressed mood

Hallucination, auditory

Impulse-control disorder

Insomnia

Panic attack

Rapid eye movements sleep abnormal

Bronchitis

Ear infection

Incision site infection

Arthralgia

Axillary pain

Folate deficiency

Hypertension

Hypotension

Thrombophlebitis

Laboratory test abnormal

Weight increased

Pericardial effusion

Seborrhoeic keratosis

Urinary incontinence

100%

80%

60%

40%

20%

Study treatment Arm

Deep Brain Stimulation

EDEN Trial Design

1Treatment groups

Experimental Treatment

Group I: Electrical StimulationExperimental Treatment1 Intervention

This is a single arm study and all subjects will receive electrical stimulation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deep Brain Stimulation

2011

Completed Phase 2

~700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Enspire DBS Therapy, Inc.Lead Sponsor

1 Previous Clinical Trials

202 Total Patients Enrolled

1 Trials studying Stroke

202 Patients Enrolled for Stroke

Andre Machado, MD, PhDPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available places left for those wishing to participate in the research?

"According to the information available on clinicaltrials.gov, this trial is not enrolling patients at present. This study was initially posted on October 26th 2016 and has been edited for the last time on August 1st 2022. Although recruitment for this specific experiment has come to a close, there are 1124 other studies seeking volunteers currently."

Answered by AI

Does this clinical trial allow for participation from individuals aged 50 and over?

"According to the criteria, only applicants aged between 25 and 75 are viable for inclusion in this clinical trial. There 45 studies open for those under 18 years old and 1077 studies available for elderly patients over 65."

Answered by AI

Which individuals are eligible to partake in this clinical research?

"This clinical trial seeks to recruit 12 individuals aged 25-75 who have experienced a unilateral middle cerebral artery (MCA) stroke within the last 3 years, resulting in moderate-severe weakening of one limb."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke

2016. "Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02835443.