The Effect of Thalamic Stimulation on Sleep Oscillations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Effect of Electrical Stimulation on Sleep.
- Who it may be relevant to
- Registry conditions: Sleep, Neuromodulation. Basic parameters: 5 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Thalamocortical Interactions and the Effect of Thalamic Stimulation on Sleep Oscillations
Overview
The thalamus plays a key role in supporting sleep and is also a target of therapeutic stimulation. This project investigates when, where, and how electrical stimulation delivered to the thalamus in humans elicits or disrupts sleep oscillations. This research is a first step to better understand how current neuromodulation therapies affect sleep and may help advance toward new therapies to improve sleep for a wide range of neurological and neuropsychological disorders.
Detailed description
The thalamus plays a key role in supporting sleep. The thalamus is also increasingly used as a stimulation therapeutic target, but the effect of thalamic stimulation on sleep has not been investigated.
We hypothesize that electrical stimulation delivered to the thalamus in humans could both elicit and disrupt sleep oscillations, such as spindles, depending on the timing and location of stimulation. We propose a study to obtain direct evidence in humans of how thalamic stimulation affects sleep.
We will test the hypothesis that stimulation during a thalamic sleep spindle disrupts it, while stimulation outside evokes a response resembling a k-complex followed by a spindle. Participants will be patients with refractory epilepsy who have semi-chronically implanted depth electrodes in the thalamus and other brain regions (\~100) as part of the pre-surgical clinical work-up. We will detect spindles and stimulate during or outside oscillations using a real-time closed-loop system that we developed. Simultaneously recording across the brain will comprehensively map the effect and extent of thalamic stimulation on sleep oscillations.
This will be the first step to unravel the effect of thalamic stimulation on sleep oscillations and maintenance. This will increase our understanding of the thalamus as a relay of sleep oscillations and could have profound implications to ensure good sleep quality for the increasing number of people implanted with therapeutic stimulation.
Interventions
- Behavioral Effect of Electrical Stimulation on Sleep
Direct electrical stimulation of thalamic nuclei and cortical structures using clinically implanted depth electrodes will allow assessing the effect of stimulation on sleep oscillations.
Primary outcome measures
- Change from pre-stimulation baseline of sleep spindle rate [Time frame: 10 to 3000 milliseconds following stimulation]
Secondary outcome measures (1)
- Number of channels with responses to stimulation [Time frame: 10 to 3000 milliseconds following stimulation]
Eligibility criteria
Inclusion criteria
- Patients getting intracranial recordings for clinical purposes who, as part of that plan, will receive thalamic electrodes.
Exclusion criteria
- previous extensive resection or large atrophy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Brigham and Women's Hospital — Boston
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07217080 · 2007P000165-1R01AG090302 · 1R01AG090302