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

NCT06710652 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-11-29

No results posted yet for this study

Summary

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.

Conditions

  • Insomnia Chronic
  • Subjective Cognitive Decline (SCD)

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.

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-06-30
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06710652 on ClinicalTrials.gov