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

NCT02585154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-04

No results posted yet for this study

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

Interventions

PROCEDURE

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

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

PROCEDURE

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

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

PROCEDURE

Deep Brain Stimulation off

Deep Brain Stimulation is turned off.

DEVICE

local field potentials and electroencephalography recordings

Simultaneous recordings of local field potentials from subthalamic nucleus and electroencephalography

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-08
Primary Completion
2017-07-01
Completion
2019-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02585154 on ClinicalTrials.gov