NCT04047498

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started May 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

August 6, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

August 1, 2019

Last Update Submit

August 5, 2019

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • The investigators will test if patients automatically adjust to the stimulation rhythm

    Immediate recording

  • The investigators will how well other motor symptoms including tremor, rigidity and bradykinesia are controlled with alternating DBS.

    Immediate recording

Study Arms (1)

Within-subjects comparison of constant and alternating DBS

EXPERIMENTAL
Device: Alternating DBS

Interventions

Alternating DBSDEVICE

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

Within-subjects comparison of constant and alternating DBS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University College London Hospitals NHS Trust

London, WC1N 3BG, United Kingdom

RECRUITING

University of Oxford

Oxford, OX3 9DU, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (1)

  • 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.

    PMID: 29760182BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Peter Brown, MD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Brown, MD

CONTACT

01865 572 482peter.brown@ndcn.ox.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants and the UPDRS examiner are blinded to the stimulation condition.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 6, 2019

Study Start

May 1, 2019

Primary Completion

September 1, 2020

Study Completion

November 1, 2020

Last Updated

August 6, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Anonymised data will be made available at https://data.mrc.ox.ac.uk/ once collected and fully analysed

Shared Documents
CSR
Time Frame
Anonymised data will be made available at https://data.mrc.ox.ac.uk/ once collected and fully analysed
Access Criteria
Please see https://data.mrc.ox.ac.uk/
More information

Locations

GB(2)