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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06656533
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 45 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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
    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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
1070 Arastradero RoadPalo AltoCalifornia94304
Maryam Ahmadi, PhD
[email protected]
951-231-3891
Andrea Goldstein Piekarski, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
1070 Arastradero Road· Palo Alto, CA

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