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Adaptive DBS for Parkinson Disease

Phase-Based Progress Estimates

1

Effectiveness

2

Safety

Movement Disorders Centre - Toronto Western Hospital, Toronto, Canada

Parkinson Disease+1 More

Adaptive DBS - Device

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

Parkinsonian symptoms, such as freezing of gait (FOG) or hypophonia, play a significant role in reducing quality of life for Parkinson disease (PD) patients, and are poorly responsive or can worsen with deep brain stimulation (DBS). Repeated adjustments of stimulation parameters may be beneficial however, continuous DBS (cDBS) does not adapt to the patients' rapidly fluctuating clinical status and does not take into account reliable and consistent state-trait biomarkers. These biomarkers can be recorded by the electrode itself as local field potentials (LFP). These LFPs can be used to guide stimulation output by means of a 'closed loop' or 'adaptive' DBS (aDBS). This is a pilot, two-phase, double-blinded, cross-over study of chronic Adaptive vs. Continuous STN DBS in patients with PD by using a novel implantable DBS system that can automatically adjust stimulation parameters based on the patient's clinical condition. The study will test the hypothesis that aDBS stimulation will treat motor fluctuations similarly to continuous stimulation but it will be superior to the latter in the treatment of speech, gait impairment and falls.

Eligible Conditions

Parkinson Disease
Adaptive vs. Continuous Subthalamic Deep Brain Stimulation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Parkinson Disease

1

1

Directional DBS guided by behavior

1

STN-PPN DBS Surgery

Study Objectives

4 Primary · 1 Secondary · Reporting Duration: Baseline, 5 months after IPG change, 8 months after battery change

Month 8

Change in Motor Outcomes (adaptive DBS vs continuous DBS arms) using Unified Parkinson's Disease Rating Scale part III (motor examination)

Month 8

Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II

Change in Gait using the Zeno Walkway by Protokinetics

Change in Quality of Life (QoL) using Parkinson's Disease Questionnaire (PDQ39)

Change in Speech Quality using the Praat software (Phonetic Sciences)

Trial Safety

Safety Progress

2 of 3

This is further along than 68% of similar trials

Other trials for Parkinson Disease

2

1

Directional DBS guided by behavior

1

STN-PPN DBS Surgery

Trial Design

1 Treatment Group

Adaptive DBS

1 of 1

Active Control

10 Total Participants · 1 Treatment Group

Primary Treatment: Adaptive DBS · No Placebo Group · Phase 2

Adaptive DBS

Device

ActiveComparator Group · 1 Intervention: Adaptive DBS · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: baseline, 5 months after ipg change, 8 months after battery change

Trial Background

Prof. Alfonso Fasano, Professor - University of Toronto

Principal Investigator

University of Toronto

Closest Location: Movement Disorders Centre - Toronto Western Hospital · Toronto, Canada

Photo of Toronto 1

Photo of Toronto 2

Photo of Toronto 3

N/AFirst Recorded Clinical Trial

2 TrialsResearching Parkinson Disease

0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

You have Parkinson's disease and are treated with bilateral deep brain stimulation using Medtronic lead.

You have a battery end of life.

Presence of disabling gait and/or balance and/or speech issues, as clinically judged by the PI and the patient.

You have disabling gait and/or balance and/or speech issues that are worsened by DBS, i.e.

You have used contact 1 and/or 2 on one hemisphere and/or 9 and/or 10 on the other one.

You have good LFP signal in at least one hemisphere.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References

Alfonso Fasano 2022. "CANadian Adaptive DBS TriAl". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05402163.

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