Alternating DBS for Stepping Control in Parkinson's Disease

Studying Stepping Control in Parkinson's Disease Using Alternating DBS

Parkinson's disease (PD) is a disabling, progressive condition characterised by severe problems with movement for which medical treatment in the longer term can be unsatisfactory. Deep brain stimulation (DBS) is a treatment, which directly stimulates the nerve cells affected inside the brain to help overcome the difficulties with movement. Classically, DBS stimulates in a manner that is constant. Many patients develop severe problems with walking, so-called freezing of gait, which can be unresponsive to constant DBS. In this study the investigators will test if left-right alternating DBS helps to improve gait problems by potentially promoting left-right alternating up- and down-modulated brain activity, which was found during walking in a previous study. The investigators will test if alternating DBS improves the ability to adjust walking speed and to walk freely compared to constant DBS.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Alternating DBS

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3BG
    • Recruiting
    • University College London Hospitals NHS Trust
    • Contact: Thomas Foltynie, MD PhD; Phone Number: 0845 155 5000; Email: t.foltynie@ucl.ac.uk
  • Oxford, United Kingdom, OX3 9DU
    • Active, not recruiting
    • University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• PD patients with bilateral subthalamic nucleus DBS electrodes and stimulators implanted for at least 6 months
• Able to give consent.

Exclusion Criteria:

• Lack of capacity to consent
• Cognitive impairment/lack of capacity to perform experimental task. The investigators will additionally conduct a short (10 min) quantitative assessment of cognitive function using a validated test (MMSE). Patients with a score < 20 will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Within-subjects comparison of constant and alternating DBS	Device: Alternating DBS; Constant DBS will be changed to DBS that is up- and downmodulated alternating between the left and right stimulation side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stepping control will be assessed as the ability to adjust the stepping speed (m/s) in each stimulation condition.	Stepping speed (m/s) will be assessed.	Immediate recording
Stepping control will be assessed as the ability to limit the variance in stepping speed (m/s) in each stimulation condition.	Stepping variance (m/s) will be assessed.	Immediate recording

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The investigators will test if patients automatically adjust to the stimulation rhythm	Stepping entrainment	Immediate recording
The investigators will how well other motor symptoms including tremor, rigidity and bradykinesia are controlled with alternating DBS.	United Parkinsons Disease Rating Scale motor (Part III) scores will be compared between stimulation conditions.	Immediate recording

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: University College, London

Publications and helpful links

General Publications

• Fischer P, Chen CC, Chang YJ, Yeh CH, Pogosyan A, Herz DM, Cheeran B, Green AL, Aziz TZ, Hyam J, Little S, Foltynie T, Limousin P, Zrinzo L, Hasegawa H, Samuel M, Ashkan K, Brown P, Tan H. Alternating Modulation of Subthalamic Nucleus Beta Oscillations during Stepping. J Neurosci. 2018 May 30;38(22):5111-5121. doi: 10.1523/JNEUROSCI.3596-17.2018. Epub 2018 May 14.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 230144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be made available at https://data.mrc.ox.ac.uk/ once collected and fully analysed
• IPD Sharing Time Frame: Anonymised data will be made available at https://data.mrc.ox.ac.uk/ once collected and fully analysed
• IPD Sharing Access Criteria: Please see https://data.mrc.ox.ac.uk/
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes