Manipulating and Optimising Brain Rhythms for Enhancement of Sleep

Summary

Treatment of sleep disturbances is mainly attempted through drug administration. However, certain drugs are associated with unwanted side effects or residual effects upon awakening (e.g. sleepiness, ataxia) which can increase the risks of falls and fractures. In addition, there can be systemic consequences of long-term use. An alternative method of manipulating sleep is by stimulating the brain to influence the electroencephalogram (EEG). To date, there have been mixed results from stimulating superficial areas of the brain and, as far as we know, there has been no systematic attempt to influence deep brain activity.

Many patients suffering from movement disorders, such as Parkinson's Disease (PD) and Multiple Systems Atrophy (MSA), also have disrupted sleep. Currently, at stages where drug treatment no longer offers adequate control of their motor symptoms, these patients are implanted with a deep brain stimulation system. This involves depth electrodes which deliver constant pulse stimulation to the targeted area. A similar system is used in patients with severe epilepsy, as well as some patients with chronic pain.

The aim of this feasibility study is to investigate whether we can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep. We will only use stimulation frequencies that have been proven to be safe for patients and frequently used for clinical treatment of their disorder. We will examine the structure and quality of sleep as well as how alert patients are when they wake up, while also monitoring physiological markers such as heart rate and blood pressure. Upon awakening, we will ask the patients to provide their subjective opinion of their sleep and complete some simple tests to see how alert they are compared to baseline condition which would be either stimulation at the standard clinical setting or no stimulation.

We hope that our study will open new ways of optimising sleep without the use of drugs, in patients who are implanted with depth electrodes. We also believe that our findings will broaden the understanding of how the activity of deep brain areas influences sleep and alertness.

Conditions

• Parkinson Disease
• MSA - Multiple System Atrophy
• Chronic Pain
• Epilepsy

Interventions

DEVICE

Deep brain stimulation

Electrical pulses from implanted generator that has already been implanted for therapeutic reasons

Sponsors & Collaborators

• Surrey Sleep Research Centre, Surrey, UK

  collaborator UNKNOWN

• Mayo Clinic

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Oxford

  lead OTHER

Principal Investigators

• Alexander L Green, FRCS(SN) · Oxford University Hospitals NHS Trust

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-03

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• United Kingdom

Study Locations