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Deep Brain Stimulation

Deep Brain Stimulation(DBS) OFF Medication for Parkinson's Disease

N/A
Waitlist Available
Led By Ritesh Ramdhani, MD
Research Sponsored by Northwell Health
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 2 years
Awards & highlights

Study Summary

This trial is studying a new way to treat Parkinson's disease by using a 60Hz subthalamic deep brain stimulator. They will be testing how well it works by measuring the patient's gait kinematics with wearable sensors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of Discriminating STN-DBS (60hz vs. High Frequency) and Medication States With Machine Learning(ML)
Gait Kinematic Response for 180 and 60Hz DBS
Secondary outcome measures
Change in Hand Tremor Severity for 180 and 60Hz DBS
Change in Speed of Limb Movements for 180 and 60Hz DBS

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%
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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation(DBS) ON MedicationExperimental Treatment1 Intervention
Subthalamic-DBS in the Levodopa ON state.
Group II: Deep Brain Stimulation(DBS) OFF MedicationExperimental Treatment1 Intervention
Subthalamic-DBS in the Levodopa OFF state.
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
460 Previous Clinical Trials
471,019 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,335 Total Patients Enrolled
The University of Tennessee, KnoxvilleOTHER
83 Previous Clinical Trials
18,535 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease
Ritesh Ramdhani, MD 2020. "Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04184791.
~5 spots leftby Apr 2025
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