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Alternating DBS for Stepping Control in Parkinson's Disease

Studying Stepping Control in Parkinson's Disease Using Alternating DBS

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04047498
Enrollment
20
Registered
2019-08-06
Start date
2019-05-01
Completion date
2020-11-30
Last updated
2019-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

DEVICEAlternating DBS

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

Sponsors

University College, London
CollaboratorOTHER
University of Oxford
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Stepping control will be assessed as the ability to adjust the stepping speed (m/s) in each stimulation condition.Immediate recordingStepping 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 recordingStepping variance (m/s) will be assessed.

Secondary

MeasureTime frameDescription
The investigators will test if patients automatically adjust to the stimulation rhythmImmediate recordingStepping entrainment
The investigators will how well other motor symptoms including tremor, rigidity and bradykinesia are controlled with alternating DBS.Immediate recordingUnited Parkinsons Disease Rating Scale motor (Part III) scores will be compared between stimulation conditions.

Countries

United Kingdom

Contacts

Primary ContactPeter Brown, MD
peter.brown@ndcn.ox.ac.uk01865 572 482

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026