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Alternating DBS for Stepping Control in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Alternating DBS
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University College London Hospitals NHS TrustRecruiting
  • University of Oxford

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Within-subjects comparison of constant and alternating DBS

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2019
Last Updated
August 5, 2019
Sponsor
University of Oxford
Collaborators
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT04047498
Brief Title
Alternating DBS for Stepping Control in Parkinson's Disease
Official Title
Studying Stepping Control in Parkinson's Disease Using Alternating DBS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Participants and the UPDRS examiner are blinded to the stimulation condition.
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Within-subjects comparison of constant and alternating DBS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Alternating DBS
Intervention Description
Constant DBS will be changed to DBS that is up- and downmodulated alternating between the left and right stimulation side.
Primary Outcome Measure Information:
Title
Stepping control will be assessed as the ability to adjust the stepping speed (m/s) in each stimulation condition.
Description
Stepping speed (m/s) will be assessed.
Time Frame
Immediate recording
Title
Stepping control will be assessed as the ability to limit the variance in stepping speed (m/s) in each stimulation condition.
Description
Stepping variance (m/s) will be assessed.
Time Frame
Immediate recording
Secondary Outcome Measure Information:
Title
The investigators will test if patients automatically adjust to the stimulation rhythm
Description
Stepping entrainment
Time Frame
Immediate recording
Title
The investigators will how well other motor symptoms including tremor, rigidity and bradykinesia are controlled with alternating DBS.
Description
United Parkinsons Disease Rating Scale motor (Part III) scores will be compared between stimulation conditions.
Time Frame
Immediate recording

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Brown, MD
Phone
01865 572 482
Email
peter.brown@ndcn.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Brown, MD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London Hospitals NHS Trust
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Foltynie, MD PhD
Phone
0845 155 5000
Email
t.foltynie@ucl.ac.uk
Facility Name
University of Oxford
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised data will be made available at https://data.mrc.ox.ac.uk/ once collected and fully analysed
IPD Sharing Time Frame
Anonymised data will be made available at https://data.mrc.ox.ac.uk/ once collected and fully analysed
IPD Sharing Access Criteria
Please see https://data.mrc.ox.ac.uk/
IPD Sharing URL
http://data.mrc.ox.ac.uk/
Citations:
PubMed Identifier
29760182
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.
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Alternating DBS for Stepping Control in Parkinson's Disease

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