ACTIVE_NOT_RECRUITING

Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

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Conditions

Parkinson DiseaseGait Disorders, NeurologicDisease ProgressionSubthalamic NucleusAccidental FallDeep Brain StimulationPostural InstabilityGait ImpairmentFreezing of GaitDBSFrequencyLowAlternatingVariableHigh

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess how alternating-frequency Deep Brain Stimulation (DBS) works to improve postural instability and gait, while also treating other motor symptoms of Parkinson Disease (PD).

Official Title

ENGAGE-PD: Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

Quick Facts

Study Start:2021-10-04
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05022147

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Bilateral STN DBS for PD
  2. * Medtronic Percept PC implanted DBS battery/pulse generator/recording system
  3. * Presence of balance and/or walking impairment and/or freezing of gait
  4. * Can walk without assistance, OFF meds, based on yes/no verbal response
  1. * Severity of gait impairment should not require dependency to walker or cane
  2. * Cannot tolerate monopolar stimulation at either of the two middle electrode contacts (prerequisite for the recording mode of the DBS) at high frequency (130 Hz) or low frequency (60 Hz).
  3. * Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases
  4. * Contraindication to physical therapy
  5. * Age \< 21
  6. * Diagnosis of dementia
  7. * Not agreeable to having video taken of entire research visit

Contacts and Locations

Principal Investigator

James Liao, MD PhD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: James Liao

  • James Liao, MD PhD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-04
Study Completion Date2025-11

Study Record Updates

Study Start Date2021-10-04
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

  • Postural Instability
  • Gait Impairment
  • Freezing of Gait
  • DBS
  • Frequency
  • Low
  • Alternating
  • Variable
  • High

Additional Relevant MeSH Terms

  • Parkinson Disease
  • Gait Disorders, Neurologic
  • Disease Progression
  • Subthalamic Nucleus
  • Accidental Fall
  • Deep Brain Stimulation