Alternating DBS for Stepping Control in Parkinson's Disease

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Device: Alternating DBS

• Registration Number: NCT04047498
• Lead Sponsor: University of Oxford

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Status Verified: 2019-07
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-05
• Last Update Submitted: 2019-08-05
• Study First Posted: 2019-08-06
• Last Update Posted: 2019-08-06
• Primary Completion: 2020-09
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Within-subjects comparison of constant and alternating DBS	Alternating DBS	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University College London Hospitals NHS Trust; 🇬🇧 London, United Kingdom

University of Oxford; 🇬🇧 Oxford, United Kingdom