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Not yet recruiting NCT06710652

Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline

No phase Interventional Insomnia Chronic Subjective Cognitive Decline (SCD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rTMS, Sham Comparator.
Who it may be relevant to
Registry conditions: Insomnia Chronic, Subjective Cognitive Decline (SCD). Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline: a Randomized Controlled Trail

Overview

Insomnia is the most common form of sleep disorder, and subjective cognitive decline (SCD) in patients with insomnia may be an ultra-early manifestation of AD. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising tool for the treatment of insomnia by modulating neural excitability and inducing plasticity. However, there is a lack of studies on rTMS treatment of cognitive impairment associated with insomnia. The efficacy and safety of rTMS for cognitive impairment in insomnia patients with SCD will be assessed by a randomized controlled trial.

Interventions

  • Device rTMS
    Stimulation coil Cool-B65 A CO, located right lingual gyrus, stimulation frequency 1Hz, stimulation intensity 80% of motor threshold, number of stimuli 3 pulses/train, train interval 1s, 500 trains in total, 1500 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week.
  • Device Sham Comparator
    Stimulation coil Cool-B65 P CO, located right lingual gyrus, stimulation frequency 1Hz, stimulation intensity 80% of motor threshold, number of stimuli 3 pulses/train, train interval 1s, 500 trains in total, 1500 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week.

Primary outcome measures

  • Change from baseline SCD-Q9 to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline MMSE to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
Secondary outcome measures (12)
  • Change from baseline MoCA scores to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline CDR to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline RAVLT to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline HAMA to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline HAMD to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline NPI to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline CDS to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline DDS to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline inflammatory factors and neuropathological markers to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline PAF to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline structural imaging indicators to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]
  • Change from baseline adverse events to 2 weeks [Time frame: Baseline vs 2 weeks after treatment]

Eligibility criteria

Inclusion criteria

  • (1) Aged 30-80 years old; (2) Diagnostic criteria for insomnia: DSM-V and ICSD-3; (3) Subjective cognitive decline. (4) Regular use of non-benzodiazepines for insomnia.

Exclusion criteria

  • (1) Refuse participants; (2) Presence of cognitive dysfunction; (3) Combined with other diseases other than central nervous system non-neurodegenerative diseases; (4) Use drugs that may affect cognition, degree of awakening and sleep quality due to other diseases; (5) Contraindications to rTMS treatment: (6) Severe complications and immune diseases; (7) Inability to cooperate; (8) Pregnancy or lactation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06710652 · rTMS-insomnia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗