The Effect of Thalamic Stimulation on Sleep Oscillations

Mass General Brigham

Status: Invitation-only

Conditions: Neuromodulation; Sleep

Treatments: Behavioral: Effect of Electrical Stimulation on Sleep

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07217080

1R01AG090302 (U.S. NIH Grant/Contract)

2007P000165-1R01AG090302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 5 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Thalamic stimulation to evoke or disrupt sleep spindles

Experimental group

Description:

Stimulation of thalamic nuclei and cortical structures using electrical stimulation.

Treatment:

Behavioral: Effect of Electrical Stimulation on Sleep