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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
Tremor refractory to multiple medication regimens and/or where the medications cause intolerable side effects
Diagnosis of Essential Tremor made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours after dbs is turned off
Awards & highlights

Study 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
Select...
My tremor doesn't improve with medications or the side effects are too severe.
Select...
I have been diagnosed with Essential Tremor by a specialist, not caused by another condition or injury.
Select...
My tremor severely affects my daily life.

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%
Back pain
5%
Head injury
5%
Speech disorder
5%
Skeletal injury
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
5%
Dyspepsia
3%
Akinesia
3%
Diabetes mellitus
3%
Device migration
3%
Intervertebral disc protrusion
3%
Postoperative wound infection
3%
Parkinson's disease
3%
Productive cough
3%
Fluid retention
3%
Skin laceration
3%
Respiratory depression
3%
Joint sprain
3%
Syncope
3%
Ingrowing nail
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Alcohol poisoning
3%
Contusion
3%
Cerebral microangiopathy
3%
Dysarthria
3%
Hypoaesthesia
3%
Memory impairment
3%
Movement disorder
3%
Monarthritis
3%
Neck pain
3%
Osteoarthritis
3%
Pain in extremity
3%
Spinal osteoarthritis
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%
Diplopia
3%
Macular degeneration
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
~700

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,861 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,832 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,685 Previous Clinical Trials
6,930,724 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

Frequently Asked Questions

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

Is it possible for persons aged 45 or above to participate in this medical examination?

"This trial is open to applicants aged 18 to 85 years old. For those under the age of 18, there are 1 specialized clinical trials and 50 for seniors that are over 65."

Answered by AI

What is the enrollment count for this medical experiment?

"Confirmed. Per clinicaltrials.gov, this study was initially published on December 4th 2021 and has been actively recruiting participants since then; the last edit to the trial's information occurred on September 7th 2022. The trial is seeking 72 subjects from a single medical facility."

Answered by AI

Is this investigation still accepting enrollees?

"Affirmative, clinicaltrials.gov data suggests that this study is currently looking for participants. First posted on December 4th 2021 and recently updated on September 7th 2022, the trial requires 72 patients to attend a single location."

Answered by AI

Are there any eligibility criteria for taking part in this trial?

"This clinical trial demands that applicants have familial tremor and are aged between 18 to 85 years old. Altogether, 72 participants will be enrolled into the study."

Answered by AI
~28 spots leftby Aug 2025