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Procedure

rTMS for Insomnia (TREAT Trial)

N/A

Waitlist Available

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Must not have

Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to complete the assessments, or are unable and/or unlikely to follow the study protocols

No regular use of benzodiazepine, opiate, thyroid, anticonvulsant or antipsychotic medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up eeg sleep parameters will be collected within one week before and within one week after 10 sessions (over two weeks)of rtms therapy. actiwatch sleep measures will be collected from one week before the baseline session to the end of the treatment session.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in improving insomnia symptoms and sleep quality. The study will involve ten adults with insomnia disorder who will receive ten

Who is the study for?

This trial is for adults with Insomnia disorder. It aims to gather preliminary data on how well rTMS, a non-invasive brain stimulation technique, can improve sleep quality when given at different times of the day.

What is being tested?

The study tests if the timing of rTMS sessions (morning or evening) affects sleep improvement in insomnia patients. Participants will undergo ten rTMS treatments over two weeks and have their sleep and brain activity measured before and after therapy.

What are the potential side effects?

rTMS is generally considered safe but may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases.

Eligibility Criteria

Exclusion Criteria

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

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I do not have severe vision, hearing, or hand movement issues that would prevent me from following study instructions.

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I do not regularly use medications for anxiety, pain, thyroid, seizures, or psychosis.

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I am not on medications that majorly affect my sleep or alertness, and I don't use illicit drugs.

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I have a history of bipolar disorder, PTSD, psychosis, or am currently experiencing depression.

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I have undergone therapy for insomnia in the last year.

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I have no history of major neurological or cardiovascular disorders.

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I have had a serious head injury with lasting effects or a brain injury in the last 2 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pittsburgh sleep quality index will be collected within one week before and within one week after the 10 sessions (over two weeks) of rtms therapy.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pittsburgh sleep quality index will be collected within one week before and within one week after the 10 sessions (over two weeks) of rtms therapy.

This trial's timeline: 3 weeks for screening, Varies for treatment, and pittsburgh sleep quality index will be collected within one week before and within one week after the 10 sessions (over two weeks) of rtms therapy. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Insomnia Severity Index (ISI)

Pittsburgh Sleep Quality Index

Secondary study objectives

Cortical Excitability

OBJECTIVE SLEEP MEASURES

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: MORNING GROUPExperimental Treatment1 Intervention

Five participants (21 to 45 years old) experiencing clinically meaningful insomnia symptoms will be enrolled and will receive 10 sessions of right dorsolateral prefrontal cortex (DLPFC) rTMS therapy in the morning over two consecutive weeks.

Group II: EVENING GROUPExperimental Treatment1 Intervention

0 / 7Eligibility criteria met