CLINICAL TRIAL

Deep Brain Stimulation for Parkinson Disease

Recruiting · 18+ · All Sexes · Great Neck, NY

Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease

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About the trial for Parkinson Disease

Treatment Groups

This trial involves 2 different treatments. Deep Brain Stimulation is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Deep Brain Stimulation
DEVICE
Experimental Group 2
Deep Brain Stimulation
DEVICE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~340

Side Effect Profile for Deep Brain Stimulation

Deep Brain Stimulation
Show all side effects
Fall
23%
Depression
15%
Restless legs syndrome
8%
Hand fracture
8%
Apathy
8%
Dystonia
5%
Tremor
5%
Back pain
5%
Dyspepsia
5%
Influenza
5%
Head injury
5%
Speech disorder
5%
Gait disturbance
5%
Skeletal injury
5%
Paraesthesia
5%
Urinary tract infection
5%
Joint sprain
3%
Parkinson's disease
3%
Axillary pain
3%
Rapid eye movements sleep abnormal
3%
Diplopia
3%
Respiratory depression
3%
Cough
3%
Dysarthria
3%
Productive cough
3%
Diabetes mellitus
3%
Implant site infection
3%
Thermal burn
3%
Rib fracture
3%
Pericardial effusion
3%
Spinal osteoarthritis
3%
Adverse drug reaction
3%
Incision site infection
3%
Weight increased
3%
Confusional state
3%
Anger
3%
Oedema peripheral
3%
Thrombophlebitis
3%
Urinary incontinence
3%
Movement disorder
3%
Laboratory test abnormal
3%
Cystitis
3%
Device migration
3%
Helicobacter gastritis
3%
Pneumonia
3%
Localised infection
3%
Staphylococcal infection
3%
Fibula fracture
3%
Contusion
3%
Alcohol poisoning
3%
Cerebral microangiopathy
3%
Syncope
3%
Memory impairment
3%
Nerve root lesion
3%
Sciatica
3%
Anxiety
3%
Hallucination, auditory
3%
Depressed mood
3%
Impulse-control disorder
3%
Arthralgia
3%
Insomnia
3%
Panic attack
3%
Ear infection
3%
Intervertebral disc protrusion
3%
Bronchitis
3%
Postoperative wound infection
3%
Bursitis
3%
Pain in extremity
3%
Monarthritis
3%
Neck pain
3%
Osteoarthritis
3%
Cyst
3%
Drug withdrawal syndrome
3%
Implant site haematoma
3%
Hypertension
3%
Macular degeneration
3%
Folate deficiency
3%
Pyrexia
3%
Fluid retention
3%
Hypotension
3%
Seborrhoeic keratosis
3%
Skin laceration
3%
Akinesia
3%
Hypoaesthesia
3%
Pleural effusion
3%
Ingrowing nail
3%
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01221948) in the Deep Brain Stimulation ARM group. Side effects include: Fall with 23%, Depression with 15%, Restless legs syndrome with 8%, Hand fracture with 8%, Apathy with 8%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Our survey is looking for people who are male or female and aged between 21 and 80 show original
have significantly better cognitive function than PD subjects who do not have DBS surgery show original
The person has an underlying gait disorder. show original
Willingness to comply with all study procedures
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Deep Brain Stimulation will improve 3 primary outcomes and 2 secondary outcomes in patients with Parkinson Disease. Measurement will happen over the course of 1 minute test session for each stimulation condition.

Change in Speed of Limb Movements
1 MINUTE TEST SESSION FOR EACH STIMULATION CONDITION
The difference in the speed of limb movements (e.g. finger taps, hand grasps, wrist rotation, leg lifts, toe taps) will be measured with an Inertial sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states.
Change in Hand Tremor Severity
1 MINUTE TEST SESSION FOR EACH STIMULATION CONDITION
The difference in tremor (e.g. rest, postural, kinetic) severity will be measured with an Inertial sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states.
Change in Gait and Balance using Wearable Sensors
1-2 MINUTE PERIOD WITH EACH STIMULATION CONDITION
Inertial Sensors will be used to quantify gait metrics (postural sway, gait cycle, circumduction) as participants conduct two 7meter walking trials for each stimulation condition ( 60Hz frequency or High Frequency) across DBS electrode pairs in both the medicated and unmedicated states.
Accuracy of Predicting Gait Response to 60hz with Machine Learning
2 YEARS
Regression models will be created using non-linear regression analysis based on random forest (RF) classifier on the raw gait sensor data acquired from the medicated and unmedicated states.
Accuracy of Predicting Best Stimulation Frequency (60hz vs. High Frequency) with Machine Learning
2 YEARS
Regression models will be created using non-linear regression analysis based on random forest (RF) classifier on all raw sensor data (gait and balance, tremor, and speed of limb movements) acquired in the medicated and unmedicated states.

Who is running the study

Principal Investigator
R. R.
Prof. Ritesh Ramdhani, MD
Northwell Health

Patient Q & A Section

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

How many people get parkinson disease a year in the United States?

The National Epidemiological Survey on Alcohol and Related Conditions III (NES-AA) is an effective means of obtaining U.S. prevalence estimates of disorders with high public health and clinical implications. More research is needed to elucidate the relationship of psychosis to disease burden and to improve clinical detection and management of schizophrenia.

Anonymous Patient Answer

Can parkinson disease be cured?

In a large series of patients with PD, the rate of improvement was only 8% and the symptom improvement only 3%, and the percentage of patients fulfilling the minimal criteria for PD remission is low, in the order of 5%.

Anonymous Patient Answer

What causes parkinson disease?

Parkinson disease is a multifactorial disease, characterized by genetic, environmental and intrinsic factors. In order to understand the mechanisms responsible for an individual's susceptibility to PD, the development of new studies is required.

Anonymous Patient Answer

What are common treatments for parkinson disease?

There are three main treatment types: L-DOPA, dopamine agonists, and MAO inhibitors. L-DOPA is usually the drug of choice to treat the motor manifestations of PD. Other drugs may include benserazide, rasagiline, amantadine, and selegiline. Lisdexamfetamine may be used in conjunction with L-DOPA in patients who are not responding well or who have intolerable side effects to L-DOPA. Dopamine agonists may be used as an initial treatment before switching to L-DOPA, but can be ineffective when used alone.

Anonymous Patient Answer

What are the signs of parkinson disease?

At rest, people with PD may have difficulty holding their head still for a prolonged period. As they take their first step, their muscles may seem very weak for a short time before they regain full strength. Other tremors may appear in the fingers as they start moving and in the course of everyday activities. These tremors are usually on one side of the body. Other problems affecting speech or swallowing may also begin. While PD usually affects the lower extremities, Parkinson's disease of the cerebellum causes uncontrollable spasmodic paralysis of the throat, and in rare cases, the eyes. A gradual loss of facial muscle coordination may lead to a grimace or other facial expressions.

Anonymous Patient Answer

What is parkinson disease?

More than one quarter of all cases of Parkinson's disease are associated with a family history of the disease. There is strong support for the autosomal dominant inheritance of the disease and a trend for an increased risk among those of Jewish and Arab ancestry. The symptoms of the disease are fairly specific and are generally consistent with descriptions in the medical literature. The prognosis, depending on the age at onset, is good.

Anonymous Patient Answer

Has deep brain stimulation proven to be more effective than a placebo?

Recent findings indicate that deep brain stimulation delivered at low current improves the motor manifestations of PD. The improvement is correlated to the stage of the disease. DFS, however, leads to further improvements without producing significant side-effects.

Anonymous Patient Answer

Have there been other clinical trials involving deep brain stimulation?

DBS trials and preliminary reports of their efficacy are relatively scarce; however, the reported results represent a trend towards higher stimulation thresholds. This may cause difficulty in the interpretation of the trial results.

Anonymous Patient Answer

How serious can parkinson disease be?

Seriousness of PD as reported by patients and their physicians is associated with some neurologic variables. The severity of PD as reported by patients may be as important as the disease duration of PD when it comes to disability status.

Anonymous Patient Answer

Have there been any new discoveries for treating parkinson disease?

There is no consensus, yet, on the best way to treat PD. A combined approach based on dopaminergic treatment and physical therapy is widely recognized as the most successful one. As for other alternative treatments, there is not much supporting evidence. Nevertheless, this was the first study to the authors knowledge which looked into the potential treatments for parkinson's disease by analysing different cell's therapies in the first time in the world. The most common treatment, the anti-Parkinson drug. Levodopa is commonly used to treat PD, so there may be an effect on the dopamine concentration in a specific area of the brain. We will see how well this is tolerated in a later phase of the study.

Anonymous Patient Answer

Who should consider clinical trials for parkinson disease?

There are important benefits and disadvantages to considering clinical trials for PD, and in evaluating whether to participate in a clinical trial, all the known factors will be taken into consideration.

Anonymous Patient Answer

How does deep brain stimulation work?

[With a high rate of success, DBS can provide long-term symptom relief.] In some cases the surgery can provide complete and durable remission of Parkinson's disease symptoms. It is also a key treatment option for patients who are not candidates for drugs and surgery for Parkinsonism, and can improve both their quality of life and the survival rate. It's recommended to first discuss with your doctors about your treatment options.

Anonymous Patient Answer
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