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Behavioural Intervention

Alternating-Frequency DBS for Parkinson's Disease (ENGAGE-PD Trial)

Phase 1
Recruiting
Led By Hubert Fernandez, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bilateral STN DBS for PD
Presence of balance and/or walking impairment and/or freezing of gait
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the intervention
Awards & highlights

ENGAGE-PD Trial Summary

This trial will test if a new DBS frequency can improve Parkinson's symptoms beyond the current standard.

Who is the study for?
This trial is for people with Parkinson's Disease who have a specific type of brain stimulation device implanted and struggle with balance or walking but can still walk without help. They shouldn't need a walker or cane, have other conditions affecting their gait, be under 21, diagnosed with dementia, or object to being filmed during the study.Check my eligibility
What is being tested?
The study tests different patterns of Deep Brain Stimulation (DBS) frequencies to see if they can improve walking and stability in Parkinson's patients. It alternates between high-frequency and low-frequency stimulations over various intervals while monitoring motor symptoms on and off Parkinson's medication.See study design
What are the potential side effects?
Potential side effects may include discomfort from the DBS adjustments, headache, dizziness, or worsening of some Parkinson’s symptoms temporarily due to frequency changes. The exact side effects will depend on individual responses to DBS frequency alterations.

ENGAGE-PD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have deep brain stimulation devices in both sides of my brain for Parkinson's.
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I have trouble with balance, walking, or I freeze while walking.
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I can walk without help and without taking any medications.

ENGAGE-PD Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Time with Tremor Present
Stride Time Coefficient of Variation
Tremor Amplitude
Secondary outcome measures
Freezing Index
Gait Velocity
LFP and EEG connectivity correlation with behavior and kinematics
+3 more

ENGAGE-PD Trial Design

1Treatment groups
Experimental Treatment
Group I: Alternating-Frequency DBSExperimental Treatment8 Interventions
In this single-arm study, all participants will receive all interventions in a crossover fashion.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Parkinson's Disease (PD) include pharmacologic agents like levodopa, dopamine agonists, and MAO-B inhibitors, as well as non-pharmacologic interventions such as Deep Brain Stimulation (DBS). Levodopa is converted to dopamine in the brain, replenishing the diminished neurotransmitter and improving motor function. Dopamine agonists mimic dopamine's effects by stimulating dopamine receptors, while MAO-B inhibitors prevent the breakdown of dopamine, prolonging its action. DBS involves the implantation of electrodes in specific brain regions to modulate neural activity, thereby improving motor symptoms and postural stability. These treatments are crucial for PD patients as they address the core issue of dopamine deficiency and abnormal neural activity, significantly enhancing quality of life by reducing motor impairments and improving overall functionality.

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Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,034 Previous Clinical Trials
1,365,413 Total Patients Enrolled
James LiaoLead Sponsor
Hubert Fernandez, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
143 Total Patients Enrolled

Media Library

Alternating-Frequency DBS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05022147 — Phase 1
Parkinson's Disease Clinical Trial 2023: Alternating-Frequency DBS Highlights & Side Effects. Trial Name: NCT05022147 — Phase 1
~0 spots leftby Jul 2024
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