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Enrolling by Invitation

NCT Number: NCT07217080

The Effect of Thalamic Stimulation on Sleep Oscillations

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.

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Key information

Conditions

Age range

5 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effect of Electrical Stimulation on Sleep

Behavioral

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 outcomes

  1. Change from pre-stimulation baseline of sleep spindle rate

    Time frame: 10 to 3000 milliseconds following stimulation

    An 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 outcomes

  1. Number of channels with responses to stimulation

    Time frame: 10 to 3000 milliseconds following stimulation

    A channel responds to stimulation if the broadband power is larger than baseline by at least 2 standard deviations, as measured from the intracranial EEG.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Thalamocortical Interactions and the Effect of Thalamic Stimulation on Sleep Oscillations

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 15, 2025
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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