Manipulating and Optimising Brain Rhythms for Enhancement of Sleep
CompletedNot applicableNCT05011773
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 s…
Study details
- Official title
- Manipulating and Optimising Brain Rhythms for Enhancement of Sleep
- Conditions
- Parkinson Disease
- MSA - Multiple System Atrophy
- Chronic Pain
- Epilepsy
- Interventions
- Device: Deep brain stimulation
- Sponsor
- University of Oxford
- Collaborators
- Surrey Sleep Research Centre, Surrey, UK; Mayo Clinic; University of California, San Francisco
- Start date
- 2021-08-03
- Primary completion
- 2022-09-30
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Either already implanted with DBS electrodes or undergoing DBS implantation in one of the defined nuclei of interest (for Surrey or Rochester: STN, PPN, Hypothalamus, PAG/PVG - for the Mayo clinic, may use hippocampus or ANT) for standard clinical care during the period of the study * Male or female, aged 18 to 85 * Be willing and able to give written and oral informed consent * Ability to complete all required study procedures including travelling to the Sleep Centre and staying overnight * By the time of the first visit to Surrey, participants should have already had their stimulation settings programmed by the Functional Neurosurgery team and have been stable on the settings for at least two weeks, as per their routine clinical care. * For patients with chronic pain, they should be stable on their current medication and settings Exclusion Criteria: * Cognitive impairment (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This is including 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. * Patients with any other medical condition that would interfere with study conduct or make it unsafe for them to participate. Such conditions may be poorly controlled diabetes, poorly controlled/end stage heart disease, renal failure as well as recurrent, uncontrolled seizures or epilepsy. * Participants who have started new medication or changed doses 3 weeks prior to a study visit may not be eligible as deemed by the PI of the study. * Patients on medication that can affect the study results (such as hypnotics - benzodiazepines and analogues), at the discretion of the PI. * Patients currently taking ketamine * Alcohol intake exceeding 28 units per week.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05011773