Long-term Stability of LFP Recorded From the STN and the Effects of DBS

NCT02915848 | Completed DMC

• 1 other identifier: UHNToronto: 12-5452-B
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Movement disorders such as Parkinson Disease, dystonia, and tremor are related to abnormalities of part of the brain known as the basal ganglia. Recently, it has been suggested that the basal ganglia works by oscillations (group of neurons cycle between activation/deactivation when stimulated) of electrical signals. A treatment that involves insertion of electrodes in the subthalamic nucleus (STN) for electrical stimulation, known as deep brain stimulation (DBS), is an established treatment for advanced Parkinson's disease. However its mechanism of action is still not completely understood. Currently, DBS utilizes an "open loop" system whereby the stimulation settings are manually adjusted depending on the patients' clinical response.

1. 1.Determine whether the local field potential (LFP) recorded from the STN is stable over a 1.5 year period.
2. 2.Address whether STN LFP is a suitable control signal, and how it should be used to change DBS parameters

Conditions

Parkinson's Disease

Keywords

deep brain stimulation; local field potential; kinematic analysis

Outcome Measures

Primary Outcomes (1)

• Clinical measure of Parkinsonism: Unified Parkinson's disease rating scale

  Clinical scales of Parkinson's disease will be measured using Unified Parkinson's disease rating scale at different time points (visits) of the study

  Through study completion, an average of 1.5 year

Secondary Outcomes (2)

• Kinetic measures of walking

  Through study completion, an average of 1.5 year

• Electrophysiologic measures of brain activity

  Through study completion, an average of 1.5 year

Study Arms (1)

PC+S group

PC+S group gets Medtronic, Activa PC+S DBS device,

Device: PC+S group

Interventions

PC+S group DEVICE

PC+S group: participants in the study will also receive a specific stimulation device (Activa PC+S, Medtronic) that is capable of recording the local field potentials (LFP). Approximately 10 participants are expected to take part in this study at UHN.

PC+S group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's disease patients scheduled to undergo STN DBS surgery

You may qualify if:

• PD Patients scheduled to undergo bilateral STN DBS surgery.
• No previous brain surgery or other neurological disorders
• No unstable medical conditions
• Able to provide informed consent and comply with study protocol

You may not qualify if:

• \. previous brain surgery or other neurological disorders unstable medical conditions

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Medtronic: collaborator

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Robert Chen, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist and Professor of Medicine (Neurology)

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 27, 2016
• Study Start: September 9, 2016
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)