The Effects of Transcranial Current Stimulation on Insomnia

Zan Wang

Status: Enrolling

Conditions: Insomnia, Psychophysiological

Treatments: Device: Sham stimulation; Device: transcranial current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07340268

TCS-V01

Details and patient eligibility

About

Effect of transcranial current stimulation on insomnia disorder

Full description

Insomnia disorder represents a prevalent clinical challenge, transcranial current stimulation has emerged as a promising noninvasive therapeutic approach; however, its specific effects on neurophysiological mechanisms underlying sleep-related brain structure and functional change, and neurobiological change remain unclear.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of insomnia disorder
• Cooperate to complete the questionnaire surveys

Exclusion criteria

• Presence of mental disorders
• Current use of central nervous system stimulants
• Use of analgesics,sedatives or hypnotic medications, theophylline preparations, steroid medications
• Alcohol abuse or regular alcohol consumption
• Diagnosis of other sleep disorders, including obstructive sleep apnea, rapid eye movement sleep behavior disorder, or restless legs syndrome
• Sleep disorders secondary to organic diseases, such as epilepsy, diabetes, or renal failure
• Shift work or irregular work schedules that disrupt normal circadian rhythms
• Use of medications affecting central nervous system function within the past one month
• Recent sleep-related confounding behaviors within the past two weeks, including staying up late, alcohol consumption, or smoking
• Presence of organic brain lesions on head MRI and contraindications to MRI examination

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

active transcranial current stimulation

Active Comparator group

Description:

14 daily 20-min, 1.1-mA sessions of active or sham transcranial current stimulation, at the beginning and end of treatment, there is a 30 second period of current fading in and out

Treatment:

Device: transcranial current stimulation

sham transcranial current stimulation

Sham Comparator group

Description:

only wore the device and had no stimulation

Treatment:

Device: Sham stimulation