NCT02585154

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

Completed NA Last updated 4 May 2021

What this trial tests

NA trial testing Deep Brain Stimulation applied through custom built external stimulator (Little et al., 2013, 2015) in Parkinson Disease in 30 participants. Completed in 31 December 2019.

Timeline

8 January 2016

Primary endpoint
1 July 2017

31 December 2019

Quick facts

Lead sponsor	University of Oxford
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	30
Start date	8 January 2016
Primary completion	1 July 2017
Estimated completion	31 December 2019
Sites	2 locations across United Kingdom

Drugs / interventions tested

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

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

University of Oxford

Who can join

Adults 18 to 74, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mechanisms Underlying Decision-Making as Revealed by Deep-Brain Stimulation in Patients with Parkinson's Disease.
   Herz DM, Little S, Pedrosa DJ, Tinkhauser G, et al · · 2018 · cited 77× · PMID 29606416 · DOI 10.1016/j.cub.2018.02.057