Optimising Brain Rhythms for Enhancement of Sleep

• Research type

  Research Study

• Full title

  Manipulating and Optimising Brain Rhythms for Enhancement of Sleep

• IRAS ID

  270711

• Contact name

  Alexander L Green

• Contact email

  alex.green@nds.ox.ac.uk

• Sponsor organisation

  Clinical Trials and Research Governance

• Clinicaltrials.gov Identifier

  NCT05011773

• Duration of Study in the UK

  1 years, 5 months, 1 days

• Research summary

  Summary of Research
  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, unsteadiness) which can increase the risks of falls and fractures. There can also be systemic consequences of long-term use. An alternative method of manipulating sleep is by stimulating the brain to influence the electroencephalogram (EEG). There have been mixed results from stimulating superficial areas of the brain while 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), have disrupted sleep. At stages where drug treatment no longer offers adequate control of their motor symptoms, they 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 some patients with chronic pain.
  We aim 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 proven to be safe for patients and frequently used for clinical treatment of their disorder. We will examine the structure and quality of sleep, while also monitoring physiological markers such as heart rate and blood pressure. We will ask the patients to provide their subjective opinion of their sleep and complete some tests to see how alert they are when they wake up.
  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.

  Summary of Results
  We studied four subjects looking at the effects of Deep Brain Stimulation on sleep. We recorded sleep architecture and associated sleep parameters (during polysomnography) such as REM latency and wake indices. One of the major findings was the ability to use DBS to 'entrain' subharmonic brain oscillations. In simple terms this means that we were able to force the brain waves into specific frequencies of nerve firing related to the stimulation that we gave. This study will act as a feasibility study for a much wider study and further investigation into 'entrainment' and how it may relate to sleep and other behavioural parameters

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  20/PR/0409

• Date of REC Opinion

  28 Oct 2020

• REC opinion

  Further Information Favourable Opinion