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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 during dbs placement surgery during active dbs
Awards & highlights
No Placebo-Only Group

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.
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.
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.
Select...
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tremor
Secondary study objectives
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)

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

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
474 Previous Clinical Trials
469,088 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
954 Previous Clinical Trials
345,929 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,819 Previous Clinical Trials
8,162,324 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
~13 spots leftby Aug 2025
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