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Deep Brain Stimulation

Deep Brain Stimulation for Essential Tremor

N/A
Recruiting
Led By Albert J Fenoy, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Essential Tremor made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
Be older than 18 years old
Must not have
Current major medical problems that affect brain anatomy, neurochemistry, or function (e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any current of history of brain disorder)
Surgical contraindications to DBS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours after dbs is turned off
Awards & highlights

Summary

This trial will test the effects of electrical stimulation on a specific nerve pathway in the brain in order to improve symptoms of Parkinson's disease.

Who is the study for?
This trial is for individuals with Essential Tremor that's not caused by another disease or injury, who haven't found relief through medications, or can't tolerate medication side effects. Their tremors must significantly affect their life quality and be confirmed by a specialist. People with severe psychiatric issues, cognitive impairments, metal in their body, recent substance abuse, pregnancy, prior brain surgery in the target area, significant neurological disorders other than ET or major medical conditions affecting the brain are excluded.Check my eligibility
What is being tested?
The study is examining how Deep Brain Stimulation (DBS) of the dentato-rubro-thalamic tract affects both the physical connections within this brain region and its activity patterns to improve tremors in Essential Tremor patients.See study design
What are the potential side effects?
While specific side effects aren't listed here for DBS treatment of Essential Tremor within this trial context; generally speaking DBS may cause headache, confusion, balance issues and possibly mood changes depending on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Essential Tremor by a specialist, not caused by another condition or injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have major health issues affecting my brain or vital organs.
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I cannot have surgery for deep brain stimulation.
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I have had surgery to target a specific area of my brain.
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I have a severe mental health condition with thoughts of harming myself.
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My family has a history of hereditary neurologic disorders, not including essential tremors.
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I have a serious nerve or brain condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours after dbs is turned off
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours after dbs is turned off for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Spectral power recorded during intraoperative electrocorticography (ECoG)
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
+4 more
Secondary outcome measures
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
Tremor

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%
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%
Akinesia
3%
Parkinson's disease
3%
Syncope
3%
Device migration
3%
Hypoaesthesia
3%
Respiratory depression
3%
Postoperative wound infection
3%
Intervertebral disc protrusion
3%
Pain in extremity
3%
Spinal osteoarthritis
3%
Osteoarthritis
3%
Macular degeneration
3%
Productive cough
3%
Diabetes mellitus
3%
Ingrowing nail
3%
Fluid retention
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation(DBS)Experimental Treatment1 Intervention
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?

Northwell HealthLead Sponsor
461 Previous Clinical Trials
471,063 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
919 Previous Clinical Trials
324,969 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,878 Total Patients Enrolled
1 Trials studying Essential Tremor
30 Patients Enrolled for Essential Tremor

Media Library

Deep Brain Stimulation (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04758624 — N/A
Essential Tremor Research Study Groups: Deep Brain Stimulation(DBS)
Essential Tremor Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT04758624 — N/A
Deep Brain Stimulation (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04758624 — N/A
~21 spots leftby Aug 2025