Thalamic Stimulation for Sleep

Enrolling by invitation at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Extensive resection, Large atrophy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electrical stimulation of the thalamus, a brain region involved in sleep, affects sleep patterns. The goal is to understand how this technique might improve sleep for individuals with various neurological and psychological disorders. Participants will receive thalamic stimulation to observe its impact on their sleep. This trial suits individuals already undergoing brain recordings with thalamic electrodes for medical reasons. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on sleep improvement techniques.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that thalamic stimulation is safe for sleep research?

Research has shown that thalamic stimulation is generally well-tolerated. Past studies suggest that this type of brain stimulation is safe. While primarily used to treat epilepsy, the safety results are promising for other uses, such as improving sleep.

In previous studies, thalamic stimulation did not cause major safety problems. Most participants experienced it without serious side effects, suggesting it could be a safe option for studying its effects on sleep patterns.

Overall, the evidence supports the safety of thalamic stimulation, even though it has mostly been tested for other conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about thalamic stimulation for sleep because it offers a novel approach by directly influencing brain activity. Unlike traditional treatments like medication or cognitive behavioral therapy, which generally aim to improve sleep indirectly, this method targets the thalamus, a critical brain area involved in sleep regulation, using electrical stimulation. This unique mechanism could potentially evoke or disrupt sleep spindles, which are essential for sleep quality, offering a more direct and potentially more effective way to manage sleep issues.

What evidence suggests that thalamic stimulation is effective for improving sleep?

In this trial, participants will receive thalamic stimulation to evoke or disrupt sleep spindles. Research has shown that stimulating the thalamus can affect sleep patterns. This stimulation can alter how different brain regions connect and communicate. One study found that thalamic stimulation changes sleep spindles, bursts of brain activity crucial for sleep and memory. These spindles help form memories during sleep, indicating they play a role in improving sleep quality. While researchers continue to study the exact effects of thalamic stimulation on sleep, early findings suggest it could be a promising method to enhance sleep and memory for those with sleep-related issues. ^{2 6 7 8 9}

Who Is on the Research Team?

Rina Zelmann, Ph.D.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for patients already undergoing intracranial recordings who will have electrodes placed in their thalamus. It's not suitable for those with significant previous brain tissue removal or atrophy.

Inclusion Criteria

I am scheduled for a brain procedure that includes placing electrodes in my thalamus.

Exclusion Criteria

I have had a major surgery to remove a large part of an organ or tissue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive thalamic stimulation to evoke or disrupt sleep spindles using electrical stimulation

Duration not specified

In-person visits for stimulation sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Effect of Electrical Stimulation on Sleep

Trial Overview The study explores the impact of electrical stimulation on sleep by targeting the thalamus, a brain region crucial for sleep regulation. The goal is to understand how this could influence sleep patterns and potentially lead to new treatments.

How Is the Trial Designed?

Group I: Thalamic stimulation to evoke or disrupt sleep spindles Experimental Treatment 1 Intervention

Stimulation of thalamic nuclei and cortical structures using electrical stimulation.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10942513/

Thalamic stimulation induced changes in network connectivity ... Results: Thalamic stimulation delivered for >1.5 hours significantly reduced pulse evoked potential amplitudes in connected areas compared to ...

2. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1392100/full

Case report: Nocturnal low-frequency stimulation of the ... Our findings reveal that high-frequency stimulation of the CM thalamus can disrupt sleep macroarchitecture and worsen seizure control in a ...

3. nature.com nature.com/articles/s41598-019-40398-9

Thalamic Reticular Nucleus Parvalbumin Neurons ... Our results support impaired TRN-PV neuron activity as a potential cause of schizophrenia-linked abnormalities in cortical delta, gamma, and spindle activity.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211124723002115

Thalamic control of sensory processing and spindles in a ... This study uses a computational model to examine the dynamics of the thalamoreticular circuit during wakefulness and sleep-like states.

5. cell.com cell.com/neuron/fulltext/S0896-6273(17)30549-4

Thalamic Spindles Promote Memory Formation during ... Our results suggest a causal role for thalamic sleep spindles in hippocampus-dependent memory consolidation, conveyed through triple coupling of slow ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07217080

The Effect of Thalamic Stimulation on Sleep Oscillations Thalamic stimulation to evoke or disrupt sleep spindles. Stimulation of thalamic nuclei and cortical structures using electrical stimulation.

7. nature.com nature.com/articles/s41467-025-62265-0

A role for the thalamus in danger evoked awakening during ... Our results revealed that centro-medial thalamic neurons play an important role in evoking sensory-driven awakening from NREM sleep consistent ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925000285

The thalamus: Structure, function, and neurotherapeutics The retrospective data published so far does suggest that RNS thalamic stimulation is safe and shows promise [[67], [68], [69], [70], [71], [72], [73], [74] ...

9. mdpi.com mdpi.com/2076-3425/13/2/324

Responsive Neurostimulation of the Anterior Thalamic ... With published safety data regarding thalamic RNS as well as ANT-DBS, evidence supporting thalamic focality in generalized epilepsies, and ...