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Enrolling By InvitationNCT07217080

The Effect of Thalamic Stimulation on Sleep Oscillations

Thalamocortical Interactions and the Effect of Thalamic Stimulation on Sleep Oscillations

Status
Enrolling By Invitation
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
5 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEffect of Electrical Stimulation on SleepDirect electrical stimulation of thalamic nuclei and cortical structures using clinically implanted depth electrodes will allow assessing the effect of stimulation on sleep oscillations.

Timeline

Start date
2025-01-06
Primary completion
2029-11-30
Completion
2029-11-30
First posted
2025-10-15
Last updated
2025-10-15

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT07217080. Inclusion in this directory is not an endorsement.