Clinical trial NCT04047498: Alternating DBS for Stepping Control in Parkinson's Disease
Official title: Studying Stepping Control in Parkinson's Disease Using Alternating DBS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2019-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Stepping control will be assessed as the ability to adjust the stepping speed (m/s) in each stimulation condition.
timeFrame: Immediate recording
measure: Stepping control will be assessed as the ability to limit the variance in stepping speed (m/s) in each stimulation condition.
timeFrame: Immediate recording
Secondary outcomes:
measure: The investigators will test if patients automatically adjust to the stimulation rhythm
timeFrame: Immediate recording
measure: The investigators will how well other motor symptoms including tremor, rigidity and bradykinesia are controlled with alternating DBS.
timeFrame: Immediate recording
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: University of Oxford
name: Peter Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.