Clinical Trial on Parkinson Disease - Clinical Trials Registry

Study Overview

Status

Withdrawn

Conditions

Parkinson Disease

Detailed Description

This is a single-center, non-randomized pilot observational study to explore the feasibility and tolerability of remotely assessing gait speed, functional mobility and balance measures in patients with Parkinson's disease experiencing medication-refractory tremor, motor complications and/or dyskinesias undergoing initiation of deep brain stimulation therapy. This study explores the feasibility of remotely performing and collecting functional assessments of gait, balance and mobility in the setting of programming deep brain stimulation (DBS).

Ten participants who are deemed surgical candidates for receiving DBS for Parkinson's disease under standard of clinical care processes (neuropsychological testing, neurology consultation and neurosurgery consultation) and have opted for the Abbott DBS system will be enrolled in the study and undergo the pre-surgical and post-surgical visits. A pre-operative in-clinic visit will take place approximately 28 days (day -42) prior to surgical DBS electrode lead implantation. An at-home assessment will take place within 14 days (day -28) of this baseline visit, still prior to surgical DBS electrode lead implantation. Participants will receive care as usual including their first post-operative clinic visit for initial programming (day 28), just like standard of care for DBS patients.

Study Type

Observational

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.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with moderate to advanced Parkinson's disease who have elected to undergo deep brain stimulation (DBS) of the subthalamic nucleus (STN) or internal globus pallidus (GPi) as standard of care for management of Parkinson's disease tremor and/or motor complications

Description

Inclusion Criteria:

Patients with with Parkinson's disease, as confirmed by the treating investigator, providing written consent to the clinical study
Participants have been determined by the treating investigator as candidates for DBS
Participants who have opted to have DBS with the remote-programming capable platform
Have internet connection at home or wherever participants will be receiving care remotely and be able to participate in telemedicine visits and remote programming

Exclusion Criteria:

Has already had prior surgical lesioning or deep brain stimulation therapy
Meets criteria for Parkinson's disease dementia in the opinion of the treating investigator
Does not have capacity for consent as judged by the treating investigator
Scores less than 24 on the Montreal Cognitive Assessment (MoCA) at standard of care DBS screening, indicating, at least, mild cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
PD patients who have elected DBS Ten individuals with moderate to advanced Parkinson's disease who have elected to undergo deep brain stimulation (DBS) of the subthalamic nucleus (STN) or internal globus pallidus (GPi) as standard of care for management of Parkinson's disease tremor and/or motor complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of remotely assessing gait speed during DBS therapy initiation Time Frame: 20 weeks	A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess gait speed.	20 weeks
Feasibility of remotely assessing functional mobility during DBS therapy initiation Time Frame: 20 weeks	A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess functional mobility.	20 weeks
Feasibility of remotely assessing balance during DBS therapy initiation Time Frame: 20 weeks	A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess balance.	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility assessment: 4 meter walk Time Frame: days -42, -28, 21, 28, 42, 56, 70, and 84	Gait speed as performed during the 4-meter walk: Measured as time taken to walk 4 meters in seconds.	days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Timed up and go (TUG) Time Frame: days -42, -28, 21, 28, 42, 56, 70, and 84	The TUG assesses mobility, balance, walking ability and fall risk in older adults and has been validated showing good agreement between in-person and telehealth and raters. On the command, "go" the patient rises from the chair, walks 3 meters at a comfortable safe pace, turns and walks back to the chair and sits down. Measured as time taken to complete task in seconds.	days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: 5 times sit to stand Time Frame: days -42, -28, 21, 28, 42, 56, 70, and 84	This is a timed task that requires the participant to stand from a seated position five times in a row. Measured as time taken to complete task in seconds.	days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: 360 degree turns Time Frame: days -42, -28, 21, 28, 42, 56, 70, and 84	The 360 degree turn test is a measure of dynamic balance in which the participant turns in a complete circle. Measured as time taken to complete task in seconds.	days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Activity-specific balance confidence (ABC) scale Time Frame: days -42, -28, 21, 28, 42, 56, 70, and 84	Self-reported confidence in performing 16 activities without losing balance. Participants rate using an 11-point likert-type scale, from 0% (no confidence) to 100% (completely confident) with 10% increments. A total score will be calculated as the mean of the items.	days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Single-leg stance Time Frame: Day -28, 21, 42, 56, 70	Amount of time participant is able to stand on one leg (performed for each leg), measured in seconds.	Day -28, 21, 42, 56, 70
Movement disorders Time Frame: day -42 and day 84	The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV The Movement Disorder Society's Unified Parkinson's Disease Rating Scales (MDS-UPDRS) consists of 65 items across four domains: non-motor experiences, motor experiences, a motor examination, and motor complications, rated from 0 (normal) to 4 (severe). Subscales and a total score are calculated by adding items. A higher score is a worse outcome and indicates more severe symptoms of Parkinson's disease.	day -42 and day 84
Quality of Life in PD Time Frame: day -42 and day 84	The Parkinson's Disease Questionnaire (PDQ-39) will be used to assess living difficulties across 8 dimensions of daily living including mobility subscores. The PDQ-39 assesses life concerns of individuals with PD. It is composed of a summary index and eight domain scores-mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each item is rated on a 0 (never) to 4 (always) scale. A higher score indicates a higher self-perceived frequency of quality of life and health problems in the past month that are due to the disease, with each domain normed to a scale on which 0 indicating never a problem and 100 always a problem. The summary index is the average of the normed domain scores. A higher score is a worse outcome for quality of life.	day -42 and day 84
Change in 3-day step count before DBS Time Frame: day -42, day 84	Step count will be measured continuously by a StepWatch4 over a 3 day period.	day -42, day 84
Change in amount of time spent with tremor and dyskinesia Time Frame: baseline, day 84	The amount of time spent with tremor and dyskinesia will be measured with the Apple watch.	baseline, day 84
Patient global impression of change Time Frame: baseline, day 28, 42, 56, 70 and 84	The Patient Global Impression - Improvement scale (CGI-I) is a 7 point scale, from 1 (normal) through to 7 (amongst the most severely ill), that requires the patient to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the study. Higher scores reflect more severe illness.	baseline, day 28, 42, 56, 70 and 84
Clinician global impression of change Time Frame: baseline, day 28, 42, 56, 70 and 84	The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale, from 1 (normal) through to 7 (amongst the most severely ill), that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the study. Higher scores reflect more severe illness.	baseline, day 28, 42, 56, 70 and 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Investigators

Principal Investigator: Ludy Shih, MD MMSc, Boston Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

H-41349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Feasibility of Remote Measures and Assessments in Deep Brain Stimulation for Parkinson's Disease (FoRMA-DBS) (FoRMA-DBS)