Closed-loop stimulation for Parkinson Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
Duke University Medical Center, Durham, NC
Parkinson Disease
Closed-loop stimulation - Device
Eligibility
18+
All Sexes
Eligible conditions
Parkinson Disease

Study Summary

This study is evaluating whether DBS surgery can be improved by implanting more than one electrode.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Closed-loop stimulation will improve 1 primary outcome and 3 secondary outcomes in patients with Parkinson Disease. Measurement will happen over the course of 24 months after IPG implant.

Month 24
Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score
Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation
Month 24
Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation
Month 24
percentage of waking hours with good "on" time

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Implanted RC+S

This trial requires 6 total participants across 2 different treatment groups

This trial involves 2 different treatments. Closed-loop Stimulation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Implanted RC+SImplanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 12 months and 24 months after ipg implant
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 12 months and 24 months after ipg implant for reporting.

Closest Location

Duke University Medical Center - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
able to give informed consent
diagnosed with Parkinson's Disease and is considered a surgical candidate for DBS
has medication-related side effects from levodopa (i.e., dyskinesias, on-off fluctuations)
has off-on improvement with levodopa of at least 30%
is available for follow-up visits for length of study

Patient Q&A Section

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

What causes parkinson disease?

Add answer

PGC may affect other organs that are close to the striatum, most notably the cardiovascular or gastrointestinal systems. These are discussed with the possible links of PGC to Parkinson disease, and a model of how PGC may cause Parkinson disease is proposed as well.

Unverified Answer

What are common treatments for parkinson disease?

Add answer

Many medications are used to treat Parkinson's disease, but medications should be reserved for those who respond well to them, or for those who are intolerant of other therapies. Most patients require both pharmacological and nonpharmacological interventions on the basis of age, symptoms, and other factors. summary:

Unverified Answer

What are the signs of parkinson disease?

Add answer

Signs of parkinson disease included tremor, bradykinesia and dysdiadochokinesia. There also may be changes in cognitive function and motivation in later disease. Early motor manifestations are more predictable in PD.

Unverified Answer

What is parkinson disease?

Add answer

Parkinson disease is a disorder of the nervous system characterized by motor symptoms, and sometimes nonspecific brain abnormalities (a-vascular or idiopathic), that may be life changing. One in 5000 people will develop Parkinson's at some point in their life.

Unverified Answer

Can parkinson disease be cured?

Add answer

The majority of patients with Parkinson's disease can be cured of the progressive condition and disability without the need to take dopamine replacement medication. In the UK, around 50% of the patients with Parkinson's disease are currently treated in this way.

Unverified Answer

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

Add answer

The estimated prevalence of this condition among elderly Americans is more than 15 million with a considerable number of these cases unrecognized. Many of these people are not aware of their condition's symptoms; thus, many are at risk for not receiving proper treatment.

Unverified Answer

What is the primary cause of parkinson disease?

Add answer

There remains considerable debate about the primary cause of PD. Current knowledge is insufficient to identify a single etiological agent(s) responsible for the neurodegeneration observed in PD. A combined effort and a combination of various fields which are all pertinent to PD-research should yield new knowledge to advance our understanding of PD pathogenesis.

Unverified Answer

What is the average age someone gets parkinson disease?

Add answer

The average age at which Parkinson's disease is diagnosed appears to be 60–70 years and the first symptom of the disease seems to be a resting tremor. This age coincides with the estimated decline in dopaminergic activity in the brain and the age when dopaminergic drugs such as levodopa become necessary. Moreover, the age of onset of levodopa is often advanced in Parkinson's disease. Thus, it is expected that the number of people with PD might increase because of the anticipated age of onset of levodopa.

Unverified Answer

What are the common side effects of closed-loop stimulation?

Add answer

Closed-loop stimulation is well tolerated as a treatment paradigm for PD. Commonly-reported therapy-related side effects are manageable in the majority of patients. These include nausea, insomnia, and tremor in the first weeks of therapy. Long-term closed-loop stimulation does not result in further increase in BMI and it does not affect triglycerides.

Unverified Answer

Is closed-loop stimulation safe for people?

Add answer

Closed-loop movement stimulation, using one-thumb stimulation of the oculomotor muscles to control movement, was well-tolerated over 3 months, without any short- or long-term adverse effects reported in our trial. More studies are needed to determine whether the technique is safe and beneficial in nonneurological conditions, and for longer periods. It would not be feasible to test it in people with a neurological impairment.

Unverified Answer

Have there been any new discoveries for treating parkinson disease?

Add answer

There have not been any new findings for Parkinson's disease so far. It is known that there is dopamine in the brain that helps to help [movement] in Parkinson's disease, but because there is no medication or therapy to [control] the dopamine, a problem for some sufferers of Parkinson's disease is movement disorders such as tremors, [bradykinesia, dyskinesia, and dysarthria]. The main [other] problem is with [gait] disorders such as unsteadiness and [slow] gait. The main way to cure the [gait] problems is through medication or a surgical procedure called Deep Brain Stimulation called DBS in deep to [control] the dopamine in the brain.

Unverified Answer

What is the latest research for parkinson disease?

Add answer

Because [PARK1] is a gene for Parkinson's disease, Parkinson's disease research is a natural area of research. Although much is still unknown about PINK1 [power] (http://www.withpower.com/parkinsons/), recent literature shows some promising drug and gene therapies in clinical trials. For example, an antisense gene therapy for the PINK1 gene showed some interesting changes in Parkinson's disease symptoms. This trial is still in progress, but initial results are encouraging. A gene therapy has also shown promise in animals with human Parkinson's Disease and it might be a future way to treat Parkinson's Disease in humans.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Parkinson Disease by sharing your contact details with the study coordinator.