Trial of Adaptive Deep Brain Stimulation

NCT03724734 | Unknown

• 1 other identifier: 256068
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Currently, treatment of Parkinson's Disease with deep brain stimulation (DBS) uses continuous high frequency stimulation. The investigators have previously shown that by controlling the stimulation using feedback from the brain and only delivering stimulation when needed side-effects like speech disturbance can be reduced. Here the investigators contrast conventional DBS with adaptive DBS while patients are awake and sleeping.

Conditions

Parkinson Disease

Keywords

subthalamic nucleus; deep brain stimulation; closed-loop

Outcome Measures

Primary Outcomes (2)

• Daytime Assessment

  Average of blinded videoed United Parkinson's Disease Rating Scale motor score repeated every 3 hours through the day. Score range 0-108. Higher score is worse outcome.

  1 day

• Night time assessment

  Average blinded videoed assessment scores of mobility during sleep arousals and awakenings. Score range 0-10. Higher score is worse outcome.

  1 night

Secondary Outcomes (7)

• Energy delivered

  1 day/night cycle

• Tremor severity

  1 day/night cycle

• Objective motor impairment

  1 day

• Speech impairment

  1 day

• Dyskinesia severity

  1 day

Study Arms (2)

Adaptive DBS

EXPERIMENTAL

We will use our custom-built externalized research system (ERS) to deliver adaptive stimulation to the subthalamic nuclei.

Device: Adaptive DBS

Conventional DBS

ACTIVE COMPARATOR

We will use our custom-built externalized research system (ERS) to deliver continuous stimulation to the subthalamic nuclei.

Device: Conventional DBS

Interventions

Adaptive DBS DEVICE

We will use our custom-built externalized research system (ERS) to allow recordings and stimulation. The device is small and lightweight and communicates wirelessly with a personal computer. The electrical connections to the DBS leads will be through temporary extensions with appropriate mechanical slack. To allow for stimulation return, a conductive clip to the ERS case will be connected to a conducting (ECG) pad placed over chest. Periodic impedance checks will ensure this connection is robust through the course of the experiment. The patient can be ambulant whilst wearing the device.

Adaptive DBS

Conventional DBS DEVICE

We will use our custom-built externalized research system (ERS) to deliver continuous conventional stimulation.

Conventional DBS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participants will be patients undergoing DBS of the subthalamic nucleus for the treatment of severe Parkinson's disease. Severe Parkinson's disease is defined as marked motor fluctuations (off periods and dyskinesias) despite optimal medical management. This is determined by the patient's clinical team.
• Able to give consent.

You may not qualify if:

• Cognitive impairment (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This includes 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.
• Intracranial bleeding, confusion, cerebrospinal fluid leak or any other complication after the first stage of surgery.

Sponsors & Collaborators

• St. George's Hospital, London: lead
• University of Oxford: collaborator

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 Officials

• Erlick Pereira, DM FRCS

  St George's University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erlick AC Pereira, DM FRCS

CONTACT

02087252375; epereira@sgul.ac.uk

Peter Brown, PhD FRCP

CONTACT

08165271866; p.brown@ndcn.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will not be told which form of stimulation is being applied and the main measures used to evaluate the outcome of the study will be video-taped performance on a number of motor tasks and the video-taping of mobility during arousals and awakenings from sleep.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Neurosurgery

Model Details: Patients will be randomised as to whether they receive conventional DBS or adaptive DBS first. Thereafter they will cross-over to the second type of stimulation.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: October 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share