What is the mechanism of action of this treatment?

Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive treatment that modulates neural activity by using magnetic fields to stimulate specific areas of the brain. This can help regulate sleep patterns by targeting brain regions involved in sleep regulation and mood. Understanding the mechanisms of rTMS is crucial for sleep patients as it provides insight into how altering neural activity can improve sleep quality, potentially offering an alternative for those who do not respond well to traditional pharmacological treatments.

What side effects are associated with this type of intervention?

Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive treatment that modulates neural activity and has been investigated for various conditions, including sleep disorders. Common side effects of rTMS include mild headaches, scalp discomfort at the stimulation site, and transient dizziness. Serious adverse effects are rare but can include seizures. Other treatments for sleep disorders that modulate neural activity, such as certain medications, may have side effects like daytime drowsiness, dizziness, and dependency issues. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved various neuromodulation techniques for different conditions, but specific approvals for sleep disorders using Repetitive Transcranial Magnetic Stimulation (rTMS) are not well-documented. However, rTMS has been approved for treatment-resistant depression, which can indirectly improve sleep quality in affected individuals. Other neuromodulation techniques, such as transcutaneous electrical nerve stimulation (TENS) and vagus nerve stimulation (VNS), have shown potential in modulating neural activity for various conditions, though their direct application to sleep disorders remains under investigation.

What other types of research exist?

Promising alternatives to rTMS for sleep patients include: 1) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing pain intensity in migraine patients and may have potential applications in sleep disorders. 2) Remote electrical neuromodulation, which involves nonpainful electrical skin stimulation and has demonstrated effectiveness in reducing acute migraine pain, suggesting potential benefits for sleep modulation.

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Procedure

rTMS for Sleep Quality

N/A

Recruiting

Research Sponsored by Gerrish MedEsthetics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, 22 to 70 years of age

Subject scored a 2 or higher on PHQ-9 sleep related question (#3), OR subject scored 2 or more on at least 2 QIDS-SR sleep related questions (#'s 1-4)

Must not have

History of head trauma associated with loss of consciousness or diagnosed as concussion

History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up various - over 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using magnetic fields to stimulate the brain can help people sleep better, feel happier, and remember things more easily.

Who is the study for?

This trial is for adults aged 22-70 who are generally healthy and experiencing poor sleep quality. Women must not be pregnant or breastfeeding and use birth control if of childbearing potential. Participants should have stable doses of any psychiatric or sleep meds for two weeks before the trial.

What is being tested?

The study tests Repetitive Transcranial Magnetic Stimulation (rTMS) to see if it can improve sleep, mood, and memory in participants. It's a pilot study, which means it's an early-stage trial to gather initial data on the effects of rTMS.

What are the potential side effects?

Possible side effects include headaches, scalp discomfort at the stimulation site, lightheadedness, brief twitching of facial muscles during treatment, or seizures (though very rare).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 70 years old.

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I have trouble sleeping, as shown by my scores on depression or sleep questionnaires.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a head injury that caused me to lose consciousness or was diagnosed as a concussion.

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I have a history of fainting, hearing issues, or tinnitus.

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I have a history of neurological or psychiatric conditions like epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ various - over 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~various - over 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and various - over 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sleep Quality - Jenkins Sleep Scale

Sleep Quality - PHQ-9 (Patient Health Questionnaire-9)

Sleep Quality - QIDS-SR (Quick Inventory of Depressive Symptomatology - Self Report)

Secondary study objectives

Memory - RAVLT Delayed Recall

Memory - RAVLT Immediate Recall (Rey Auditory Verbal Learning Test)

Mood - PANAS (Positive and Negative Affect Schedule)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rTMS

2016

Completed Phase 3

~840

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive treatment that modulates neural activity by using magnetic fields to stimulate specific areas of the brain. This can help regulate sleep patterns by targeting brain regions involved in sleep regulation and mood. Understanding the mechanisms of rTMS is crucial for sleep patients as it provides insight into how altering neural activity can improve sleep quality, potentially offering an alternative for those who do not respond well to traditional pharmacological treatments.