Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06671457

Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders

Led by Zhen Wang · Updated on 2025-08-21

40

Participants Needed

1

Research Sites

72 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.

CONDITIONS

Official Title

Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Diagnosed with insomnia disorder according to DSM-5
  • No psychiatric medications in the past 8 weeks or stable psychiatric medication for 8 weeks (excluding benzodiazepines)
  • Insomnia Severity Index (ISI) score above 10
  • At least junior high school education level
Not Eligible

You will not qualify if you...

  • Diagnosed with disorders other than insomnia, anxiety, or depressive disorder according to DSM-5
  • Current use of benzodiazepines as sleep aids
  • Moderate to severe anxiety or depression (HAMD-17 score > 16 or HAMA score > 24)
  • Obstructive sleep apnea syndrome
  • Previous treatment with ECT, rTMS, tES, or cognitive behavioral therapy for insomnia
  • Severe physical illnesses or conditions causing seizures or intracranial hypertension, including cardiovascular or respiratory diseases
  • History of neurological disorders such as epilepsy, stroke, brain injury, or brain surgery
  • Presence of implantable medical devices like intracranial stents, pacemakers, coronary stents, or cochlear implants
  • Severe negative thoughts or high suicide risk
  • Pregnant or planning to conceive soon

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

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Research Team

Z

Zhen Wang, PhD,MD

CONTACT

Z

Zhen Wang, PhD,MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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