Alternating DBS for Stepping Control in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Studying Stepping Control in Parkinson's Disease Using Alternating DBS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04047498
• Other study ID #: 230144
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 2020

Study information

• Verified date: July 2019
• Source: University of Oxford
• Contact: Peter Brown, MD
• Phone: 01865 572 482
• Email: peter.brown[@]ndcn.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals NHS Trust	London
United Kingdom	University of Oxford	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	University College, London

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The investigators will test if patients automatically adjust to the stimulation rhythm	Stepping entrainment	Immediate recording
Secondary	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.	Immediate recording