Studying Movement Control in Parkinson's Disease Using Closed Loop Deep Brain Stimulation

NCT02585154 | Completed

• 1 other identifier: 168287
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Parkinson's disease is a common, disabling, progressive condition characterised by severe problems with movement for which medical treatment in the longer term can be unsatisfactory. Deep brain stimulation is a treatment, which directly stimulates the nerve cells affected inside the brain to help overcome the difficulties with movement. Classically, deep brain stimulation stimulates in a manner that is constant and independent of a patients underlying condition as reflected in their brainwave activity. Recent research has suggested that adjusting deep brain stimulation in real time using analyses of brain signals recorded from deep brain stimulation electrodes (termed closed loop deep brain stimulation) nay be better than classical deep brain stimulation in alleviating difficulties with movement. However, it remains unclear whether closed-loop deep brain stimulation also leads to fewer unwanted side effects on movement control. In order to answer this question, the investigators will analyze deep brain stimulation activity and activity recorded from the surface of the head in Parkinson's disease patients undergoing deep brain stimulation surgery. During the recordings patients will perform different movement tasks. Deep brain stimulation has been found to reduce patients' ability to suppress inappropriate movements in certain tasks and performance in these tasks will be the core point of interest. The recordings will be conducted three times: During closed loop deep brain stimulation, classical deep brain stimulation and while the stimulator is turned off. This will allow the investigators to assess putative differences in the effect of closed loop and classical deep brain stimulation with regards to wanted and unwanted effects on movement control and to elucidate their correlates in the brain.

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (2)

• Ability to suppress inappropriate movements as measured by motor tasks (accuracy measured in %)

  Outcome will be assessed on day of experimental sessions (interventions), i.e. the time frame corresponds to the study duration.

• Ability to suppress inappropriate movements as measured by motor tasks (response time measured in s)

  Outcome will be assessed on day of experimental sessions (interventions), i.e. the time frame corresponds to the study duration.

Secondary Outcomes (2)

• Local field potential spectra during open-loop deep brain stimulation, closed-loop deep brain stimulation and no deep brain stimulation

  Outcome will be assessed on day of experimental sessions (interventions), i.e. the time frame corresponds to the study duration.

• Connectivity between neural regions during open-loop deep brain stimulation, closed-loop deep brain stimulation and no deep brain stimulation

  Outcome will be assessed on day of experimental sessions (interventions), i.e. the time frame corresponds to the study duration.

Study Arms (3)

Closed-loop Deep Brain Stimulation

EXPERIMENTAL

Closed-loop Deep Brain Stimulation

Procedure: closed-loop Deep Brain Stimulation applied through custom built external stimulator (Little et al., 2013, 2015); Device: local field potentials and electroencephalography recordings

Open loop Deep Brain stimulation

ACTIVE COMPARATOR

Open loop Deep Brain stimulation

Procedure: Deep Brain Stimulation applied through custom built external stimulator (Little et al., 2013, 2015); Device: local field potentials and electroencephalography recordings

No Deep Brain Stimulation

OTHER

No Deep Brain Stimulation

Procedure: Deep Brain Stimulation off; Device: local field potentials and electroencephalography recordings

Interventions

Deep Brain Stimulation applied through custom built external stimulator (Little et al., 2013, 2015) PROCEDURE

'Classical' high-frequency Deep Brain Stimulation, which is applied irrespective of ongoing brain activity.

Open loop Deep Brain stimulation

closed-loop Deep Brain Stimulation applied through custom built external stimulator (Little et al., 2013, 2015) PROCEDURE

Deep Brain Stimulation, which is applied depending on ongoing brain activity.

Closed-loop Deep Brain Stimulation

Deep Brain Stimulation off PROCEDURE

Deep Brain Stimulation is turned off.

No Deep Brain Stimulation

local field potentials and electroencephalography recordings DEVICE

Simultaneous recordings of local field potentials from subthalamic nucleus and electroencephalography

Closed-loop Deep Brain Stimulation; No Deep Brain Stimulation; Open loop Deep Brain stimulation

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participants will be Parkinson's disease patients undergoing deep brain stimulation of the subthalamic nucleus (STN).
• Whether or not a patient is selected for deep brain stimulation surgery is determined by the patient's clinical team purely on independent clinical grounds.
• Only those patients who have been accepted for deep brain stimulation treatment by their clinical neurologist and functional neurosurgeon will be introduced to the project and have their details passed on to the research team for further information and formal consenting.
• Able to give informed consent.

You may not qualify if:

• Lack of capacity to consent (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This is including anyone who, in the opinion of the clinician taking consent, is unlikely to retain sufficient mental capacity for the duration of their involvement in the study.
• Cognitive impairment/lack of capacity to perform experimental task.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (2)

University College London Hospitals NHS Trust

London, WC1N 3BG, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (2)

• Little S, Pogosyan A, Neal S, Zavala B, Zrinzo L, Hariz M, Foltynie T, Limousin P, Ashkan K, FitzGerald J, Green AL, Aziz TZ, Brown P. Adaptive deep brain stimulation in advanced Parkinson disease. Ann Neurol. 2013 Sep;74(3):449-57. doi: 10.1002/ana.23951. Epub 2013 Jul 12.

  PMID: 23852650 BACKGROUND

• Little S, Beudel M, Zrinzo L, Foltynie T, Limousin P, Hariz M, Neal S, Cheeran B, Cagnan H, Gratwicke J, Aziz TZ, Pogosyan A, Brown P. Bilateral adaptive deep brain stimulation is effective in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2016 Jul;87(7):717-21. doi: 10.1136/jnnp-2015-310972. Epub 2015 Sep 30.

  PMID: 26424898 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinded video assessment
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: blinded cross-over study of no deep brain stimulation, conventional deep brain stimulation and adaptive deep brain stimulation

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 23, 2015
• Study Start: January 8, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 31, 2019
• Last Updated: May 4, 2021

Record last verified: 2017-10

Locations

GB (2)