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Accelerating the development of new gamma-tACS technology to improve insomnia disorder and exploring the neurological mechanisms in a multi-center study

Accelerating the development of new gamma-tACS technology to improve insomnia disorder and exploring the neurological mechanisms in a multi-center study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095831
Enrollment
Unknown
Registered
2025-01-14
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia disorder

Interventions

Accelerated gamma-tACS groups:Accelerated gamma-tACS treatment
sham gamma-tACS groups:sham gamma-tACS treatment

Sponsors

Affiliated Kangning Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 to 60; 2.Diagnostic criteria for insomnia disorder in the International Classification of Diseases and Related Health Problems, 11th Revision (ICD-11); 3.Total PSQI item score >5; 4.Right sharp hand; 5.The patient's physical examination, medical history, vital signs, blood, urine and stool routines, liver and kidney functions, electrolytes, electrocardiogram and electroencephalogram are normal; 6.After fully understanding the safety of transcranial alternating current stimulation (tACS), the patient is willing to actively cooperate with the treatment and sign the informed consent by himself/herself and his/her family.

Exclusion criteria

Exclusion criteria: 1.Patients with severe physical, infectious and immune system diseases; 2.Patients with severe neurological diseases, mental retardation or organic brain diseases; 3.Patients with metal or electronic instruments placed in their bodies, such as intracranial metal foreign bodies, cochlear implants, pacemakers and stents, and other metal foreign bodies; 4.Patients at risk of seizures, with previous craniocerebral diseases, head trauma, alcoholism, EEG abnormalities, MRI evidence of structural abnormalities in the brain, or a family history of epilepsy; 5.Received ECT within 2 months prior to enrollment; 6.Those with psychotic symptoms requiring a combination of should antipsychotic drugs; 7.Those who are pregnant, breastfeeding, or planning a pregnancy during the trial;

Design outcomes

Primary

MeasureTime frame
Clinical Scale Assessment;

Secondary

MeasureTime frame
Electromyographic changes;EEG changes;Near infrared functional imaging;3.0T nuclear magnetic (MRI);

Countries

China

Contacts

Public ContactDongsheng Zhou

Affiliated Kangning Hospital of Ningbo University

wyzhouds@sina.com+86 574 2630 2565

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026