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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

Select...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,027 Previous Clinical Trials

1,364,266 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

Frequently Asked Questions

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

What is the primary aim of this research endeavor?

"This medical trial hopes to assess the diminution of tremor amplitude as its primary outcome measure. Other metrics that will be monitored include step cadence (a marker of bradykinesia derived from motion sensors), EEG and LFP connectivity correlation with behaviour, kinematics, and gait velocity (another indicator of bradykinesia)."

Answered by AI

What is the participant capacity of this experiment?

"Affirmative. Clinicaltrials.gov has detailed that this investigation, which was initially posted on October 4th 2021, is currently looking for participants. A total of 12 individuals need to be enlisted from 1 medical centre."

Answered by AI

What has been established regarding the safety of Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation for patients?

"The safety of Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation is rated 1 out of 3 on our Power scale as this trial falls into Phase 1 category. This means there are little to no data available regarding the treatment's efficacy and security."

Answered by AI

Is enrollment still open for this experiment?

"According to the latest data on clinicaltrials.gov, this ongoing experiment is actively recruiting study participants. The trial was initially posted in October 2021 and has undergone updates up until September 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

James Liao 2021. "Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05022147.

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