The Effect of Thalamic Stimulation on Sleep Oscillations

NCT ID: NCT07217080

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2029-11-30

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.

Conditions

Sleep; Neuromodulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Thalamic stimulation to evoke or disrupt sleep spindles

Stimulation of thalamic nuclei and cortical structures using electrical stimulation.

Group Type: EXPERIMENTAL

Effect of Electrical Stimulation on Sleep

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rina Zelmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rina Zelmann, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1R01AG090302

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2007P000165-1R01AG090302

Identifier Type: -

Identifier Source: org_study_id