Recruiting

rTMSOptimizing the Timing of rTMS to Enhance the Administration of Insomnia Treatment

Sponsor:

Stanford University

Code:

NCT06656533

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 25 - 45

Healthy Volunteers: Not accepted

Interventions

Repeated Transcranial magnetic stimulation (rTMS)

Study Details

Brief summary:

Repetitive transcranial magnetic stimulation (rTMS) has shown to be a promising technique for improving insomnia symptoms and sleep quality. However, the impact of circadian rhythmicity on rTMS sessions and its potential influence on insomnia therapy remains unclear. Moreover, the effect of rTMS on objective sleep parameters is not fully established. The objective of this pilot study is to establish key feasibility and preliminary data that would be used for an R-level grant application focused on optimizing rTMS therapy for insomnia. The investigators will acquire feasibility data from ten adults with Insomnia disorder. Participants will receive ten sessions rTMS over two weeks, either in the morning or evening. Sleep parameters will be assessed before, during, and after completion of rTMS and brain cortical excitability will be collected before rTMS treatment. The investigators aim to 1) evaluate the impact of circadian timing of rTMS sessions on subjective and objective sleep outcomes, 2) assess the time course of improvements in sleep outcomes, and 3) examine the association between sleep outcomes and cortical excitability. The overarching goal of this work is to optimize rTMS therapy for insomnia by investigating the impact of circadian timing on rTMS sessions and assessing potential variations in subjective and objective measures of sleep.

Conditions

Insomnia

Study ID

NCT06656533

Start date

Mar 1, 2025

Status verified date

Apr, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 25 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

Males and females of any racial or ethnic group, aged 25-45 (inclusive)
Insomnia diagnosis via the DUKE
Fluent and literate in English
Written, informed consent
Reside within 60 miles of Stanford University

Exclusion Criteria:

Presence of other sleep or circadian rhythm disorders that significantly contribute to their sleep disturbance. The presence of these disorders will be assessed by the DUKE structured interview for sleep disorders.
No regular use of benzodiazepine, opiate, thyroid, anticonvulsant or antipsychotic medications
Use of psychotropic medications that would significantly impact sleep, alertness, and no illicit drugs.
Excessive alcohol consumption (\>14 drinks per week or \> 4 drinks per occasion)
Presence of suicidal ideations representing elevated risk as determined by the Beck Depression Inventory (score of \> 0 on BDI question #9).
History of neurological or cardiovascular disorders, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, stroke, seizures or epilepsy, diabetes, hypo- or hyperthyroidism, head trauma with loss of consciousness greater than thirty minutes.
Substance abuse or dependence
History of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities OR traumatic brain injury in the past two months
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
Pregnant or breast feeding
Current or lifetime history of bipolar disorder, PTSD or psychosis or current depression
Received cognitive behavioral therapy for insomnia within the past year
Current exposure to trauma, or exposure to trauma within the past 3 months
Working a rotating shift that overlaps with 2400h
Individuals who were high risk for sleep apnea on the Berlin Questionnaire and are not CPAP adherent
Participants with a current psychiatric disorder who are also on medications that significantly increase the risk of seizure. The antidepressants clomipramine, bupropion, maprotiline will be excluded because they are known to increase risk of up to 0.5-2.2% from a population reference range of 0.07- 0.08% in the general population and 0.1-4% in the population of people taking antidepressants.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MORNING GROUP

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.

experimental: EVENING GROUP

Interventions

Repeated Transcranial magnetic stimulation (rTMS)

Transcranial Magnetic Stimulation (TMS) involves a procedure where parts of the participants brain will be non-invasively (i.e. indirectly) stimulated by magnetic pulses. These magnetic pulses induce very brief activity in brain areas underlying the TMS coil. TMS will be performed by giving repetitive pulses (rTMS). rTMS has shown promise to reduce cortical hyperexcitability and to improve subjective measures of sleep quality and insomnia symptoms in patients with insomnia disorder. The goal of this study is to optimize the impact of rTMS therapy on sleep outcomes for patients with insomnia disorder.

Primary outcome measure

Insomnia Severity Index (ISI) [ Time Frame: Insomnia severity index will be collected within one week before and within one week after the 10 sessions (over two weeks) of rTMS therapy. ]
Pittsburgh Sleep Quality Index [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Maryam Ahmadi, PhD

9512313891 maryamahmadi529@gmail.com

Andrea Goldstein Piekarski, PhD

agoldpie@stanford.edu

Locations

1070 Arastradero Road

Recruiting

Palo Alto, California, United States, 94304

Contacts

Maryam Ahmadi, PhD

951-231-3891 ahmadi1@stanford.edu

Principal Investigator:

Andrea Goldstein Piekarski, PhD

More Information

Sponsor

Stanford University

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

Sleep
Insomnia
rTMS Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-04-23.