Alternating DBS for Stepping Control in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Participants and the UPDRS examiner are blinded to the stimulation condition.

Study Groups

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Within-subjects comparison of constant and alternating DBS

Group Type EXPERIMENTAL

Alternating DBS

Intervention Type DEVICE

Constant DBS will be changed to DBS that is up- and downmodulated alternating between the left and right stimulation side.

Interventions

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Alternating DBS

Constant DBS will be changed to DBS that is up- and downmodulated alternating between the left and right stimulation side.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No