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

F

Fujian Medical University (FJMU)

Status

Not yet enrolling

Conditions

Subjective Cognitive Decline (SCD)
Insomnia Chronic

Treatments

Device: rTMS
Device: Sham Comparator

Study type

Interventional

Funder types

Other

Identifiers

NCT06710652
rTMS-insomnia

Details and patient eligibility

About

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.

Enrollment

66 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

66 participants in 2 patient groups

rTMS
Experimental group
Treatment:
Device: rTMS
sham rTMS
Sham Comparator group
Treatment:
Device: Sham Comparator

Trial contacts and locations

0

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Central trial contact

Xiaodong Pan

Data sourced from clinicaltrials.gov

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