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The Effect of Thalamic Stimulation on Sleep Oscillations

Thalamocortical Interactions and the Effect of Thalamic Stimulation on Sleep Oscillations

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07217080
Enrollment
50
Registered
2025-10-15
Start date
2025-01-06
Completion date
2029-11-30
Last updated
2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromodulation, Sleep

Keywords

Sleep, Spindles, Thalamus, electroencephalography, intracranial EEG, Neuromodulation

Brief 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.

Interventions

BEHAVIORALEffect 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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from pre-stimulation baseline of sleep spindle rate10 to 3000 milliseconds following stimulationAn increase in spindle rate is achieved if at least 50% of trials evoke a spindle as measured on intracranial EEG following stimulation. A spindle is evoked when the power in the 10-16Hz band is larger than pre-stimulation baseline power by at least 2 standard deviations.

Secondary

MeasureTime frameDescription
Number of channels with responses to stimulation10 to 3000 milliseconds following stimulationA channel responds to stimulation if the broadband power is larger than baseline by at least 2 standard deviations, as measured from the intracranial EEG.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026