The Effect of Thalamic Stimulation on Sleep Oscillations

NCT07217080 | Enrolling By Invitation

• 2 other identifiers: 2007P000165-1R01AG0903021R01AG090302
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep; Neuromodulation

Keywords

Sleep; Spindles; Thalamus; electroencephalography; intracranial EEG; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Change from pre-stimulation baseline of sleep spindle rate

  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.

  10 to 3000 milliseconds following stimulation

Secondary Outcomes (1)

• Number of channels with responses to stimulation

  10 to 3000 milliseconds following stimulation

Study Arms (1)

Thalamic stimulation to evoke or disrupt sleep spindles

EXPERIMENTAL

Stimulation of thalamic nuclei and cortical structures using electrical stimulation.

Behavioral: Effect of Electrical Stimulation on Sleep

Interventions

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.

Thalamic stimulation to evoke or disrupt sleep spindles

Eligibility Criteria

• Age: 5 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients getting intracranial recordings for clinical purposes who, as part of that plan, will receive thalamic electrodes.

You may not qualify if:

• previous extensive resection or large atrophy

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02114-2696, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

Location

Study Officials

• Rina Zelmann, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 15, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Beginning 1 year after publication with no end date
• Access Criteria: We will share electrophysiological data with the scientific community via the Data Archive for the BRAIN Initiative (DABI), or another NIH-approved database, where we will offer access to our database of neural activity.

Locations

US (2)