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Trial of Adaptive Deep Brain Stimulation

NCT03724734 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-04-16

No results posted yet for this study

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

Interventions

DEVICE

Adaptive DBS

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.

DEVICE

Conventional DBS

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

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • St. George's Hospital, London

    lead OTHER

Principal Investigators

  • Erlick Pereira, DM FRCS · St George's University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2020-01-31
Completion
2020-05-31

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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 NCT03724734 on ClinicalTrials.gov