Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation for Parkinson Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
Cleveland Clinic Foundation, Cleveland, OH
Parkinson Disease+6 More
Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation - Device
Eligibility
18+
All Sexes
Eligible conditions
Parkinson Disease

Study Summary

This study is evaluating whether a surgery which reduces blood flow in a brain area called the Subthalamic Nucleus (STN) can improve motor symptoms in people with Parkinson Disease.

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Eligible Conditions

  • Parkinson Disease
  • Disease Progression
  • Nervous System Diseases
  • Duck Gait
  • Deep Brain Stimulation (DBS)
  • Falls, Accidental
  • Subthalamic Nucleus
  • Gait Disorders, Neurologic

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation will improve 3 primary outcomes and 6 secondary outcomes in patients with Parkinson Disease. Measurement will happen over the course of During the intervention.

During the intervention
Freezing Index
Gait Velocity
LFP and EEG connectivity correlation with behavior and kinematics
LFP and EEG power spectrum correlation with behavior and kinematics
Percentage of Time with Tremor Present
Step Cadence
Stride Time Coefficient of Variation
Total Freezing Time
Tremor Amplitude

Trial Safety

Trial Design

2 Treatment Groups

Control
Alternating-Frequency DBS

This trial requires 12 total participants across 2 different treatment groups

This trial involves 2 different treatments. Alternating, 10 Sec High-Frequency, 10 Sec Low-Frequency Stimulation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Alternating-Frequency DBSIn this single-arm study, all participants will receive all interventions in a crossover fashion.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during the intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly during the intervention for reporting.

Who is running the study

Principal Investigator
H. F.
Hubert Fernandez, Director, Center for Neurological Restoration
The Cleveland Clinic

Closest Location

Cleveland Clinic Foundation - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Bilateral STN DBS for PD
Medtronic Percept PC implanted DBS battery/pulse generator/recording system
Presence of balance and/or walking impairment and/or freezing of gait
Can walk without assistance, OFF meds, based on yes/no verbal response

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 are common treatments for parkinson disease?

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There are many treatments for Parkinson’s disease, depending on the cause and severity of the disease. Treatment is often aimed at slowing down the progression of symptoms, managing their symptoms rather than removing them.\n

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What is parkinson disease?

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Parkinson is not so complicated to define. Clinical symptoms include, tremors in arms and legs, and slowness in movements. In contrast, [neuroimaging studies] show abnormalities in the brain's circuitry as well as on an anatomic level. It is very important to find a way to combine these two studies as well as [neurological studies], to get full picture of a person with Parkinson disease(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4309822). The [CherryRed] Power(https://www.cambria.

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What are the signs of parkinson disease?

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Parkinson disease includes typical signs such as tremor affecting the hands, fingers and/or face, a slow speech rate and difficulty walking. Additionally, the signs may include droopy eyelid, shaking and/or slowness of movement, rigidity and muscle weakness in both arms and/or legs. The signs can be mistaken for normal aging.\n

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Can parkinson disease be cured?

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Despite being a chronic motor disorder, Parkinson's disease is never completely healed if the treatment for parkinsonian symptoms fails. Parkinson's disease can be cured only by eliminating the cause(s) of this clinical disease. It has never been shown to be possible to cure the underlying neurodegenerative cause. However, there are some drugs already being used which may have some ability to slow down the progress of the disease.

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What causes parkinson disease?

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parkinson's disease occurs when a person's cells, known as neurons, start to die, with signs and symptoms worsening progressively. It is not entirely clear what causes the cell death. Many factors, such as genetics, environmental exposures, and lifestyle factors, have been proposed. But there is no single, easy-to-know, absolute cause of parkinson's disease.\n

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

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The US Census Bureau reports an estimated total of about 564,200 new cases of Parkinson disease, comprising a total of 558,900 new diagnoses. This is 22.6% of the US population, with an estimated yearly incidence of 5.0 cases per 100,000 inhabitants. Because PD is a progressive disease that destroys dopaminergic neurons in the brain, the cumulative annual prevalence and incidence is expected to rise in the next few decades. A projected cumulative annual increase of 11.6% in new cases of PD and 6.7% in new cases of PD with eventual death is expected in the US population as a whole by 2050.

Unverified Answer

Is alternating, 10 sec high-frequency, 10 sec low-frequency stimulation typically used in combination with any other treatments?

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AF stimulation can be used as a combined stimulation method with any other therapeutic interventions. Further prospective, randomized studies are indicated, at least in symptomatic advanced PD.

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What are the common side effects of alternating, 10 sec high-frequency, 10 sec low-frequency stimulation?

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Subjects with PD and an implanted pacemaker or cochlear implant can safely use stimulating devices such as the Stentrode. The most frequent side-effects were transient Paresthesias, which may occur especially when switching from one stimulation to another.

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What is the latest research for parkinson disease?

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This article provides an overview of the most recent recent research on the pathology and treatment of Parkinson disease, including new advances in dopamine replacement therapy, non-invasive brain imaging studies, and the neuroprotective and symptomatic properties of the dopa decarboxylase aryl hydrocarbon receptor nuclear translocator (ARNT) ligand LKB3010.

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What is the average age someone gets parkinson disease?

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The average age of onset of PD (PDD) is 63 years of age. Symptoms typically progress over many years as an insidious disease with worsening quality of life. Most people live well in excess of ten years after the onset of symptoms while the disease progresses and worsens. The symptoms, physical capacity, and the activity level all decline over a long period of time. Even so, some people experience a relatively good and active life in the final decades of life due to a delay in the progression and progression of the disease, as well as the age of onset. A long period of untreated disease and subsequent dementia in early old age can be highly destructive even when the disease progresses slowly.

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Has alternating, 10 sec high-frequency, 10 sec low-frequency stimulation proven to be more effective than a placebo?

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Stimulation is a versatile and well tolerated adjunct for deep brain stimulation applications. The frequency, duration of stimulation, pattern, and voltage of an alternating or repetitive stimulation paradigm does not influence clinical outcome.

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What are the latest developments in alternating, 10 sec high-frequency, 10 sec low-frequency stimulation for therapeutic use?

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The most recent advance in the field of an alternating, high-frequency, low-frequency stimulation devices for therapeutic use is the reduction of implanted leads to a single-electrode configuration which makes stimulation of the contralateral brain possible. It also allows for avoidance of implanted lead migration. We propose a new stimulation strategy in neurostimulation: alternating, high-frequency, low-frequency stimulation.

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