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

NCT06656533 | Recruiting FDA Device

• 1 other identifier: 76766
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Sleep; Insomnia; rTMS Therapy

Outcome Measures

Primary Outcomes (2)

• Insomnia Severity Index (ISI)

  Improvement in insomnia symptoms will be assessed using the Insomnia Severity Index (ISI). ISI is a 7-item self-report questionnaire designed to assess the severity of insomnia symptoms and their impact on daily functioning. Each question is scored on a 5-point Likert scale, with ratings from 0 (no problem) to 4 (very severe problem).

  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

  Improvement in subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). PSQI is a widely used questionnaire that assesses sleep quality and disturbances over one month. It includes seven components and ranges from 0 to 21, with higher scores indicating poorer sleep quality. A score above 5 is generally considered indicative of poor sleep quality.

  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.

Secondary Outcomes (2)

• OBJECTIVE SLEEP MEASURES

  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.

• Cortical Excitability

  Cortical excitability will be measured during the first therapy session, before the first rTMS therapy.

Study Arms (2)

MORNING GROUP

EXPERIMENTAL

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.

Other: Repeated Transcranial magnetic stimulation (rTMS)

EVENING GROUP

EXPERIMENTAL

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 evening over two consecutive weeks.

Other: Repeated Transcranial magnetic stimulation (rTMS)

Interventions

Repeated Transcranial magnetic stimulation (rTMS) OTHER

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.

EVENING GROUP; MORNING GROUP

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

1070 Arastradero Road

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (2)

• Ly JQM, Gaggioni G, Chellappa SL, Papachilleos S, Brzozowski A, Borsu C, Rosanova M, Sarasso S, Middleton B, Luxen A, Archer SN, Phillips C, Dijk DJ, Maquet P, Massimini M, Vandewalle G. Circadian regulation of human cortical excitability. Nat Commun. 2016 Jun 24;7:11828. doi: 10.1038/ncomms11828.

  PMID: 27339884 RESULT

• Nardone R, Sebastianelli L, Versace V, Brigo F, Golaszewski S, Pucks-Faes E, Saltuari L, Trinka E. Effects of repetitive transcranial magnetic stimulation in subjects with sleep disorders. Sleep Med. 2020 Jul;71:113-121. doi: 10.1016/j.sleep.2020.01.028. Epub 2020 Feb 19.

  PMID: 32173186 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Maryam Ahmadi, PhD

CONTACT

9512313891; maryamahmadi529@gmail.com

Andrea Goldstein Piekarski, PhD

CONTACT

agoldpie@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 24, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)