Treatment-resistant insomnia
Conditions
Interventions
active tDCS+ ZOL:The treatment regimen consisted of transcranial direct current stimulation (tDCS) with the anode positioned over the left dorsolateral prefrontal cortex and the cathode over the right
active tDCS + placebo:The tDCS group will receive active tDCS treatment (identical to that described for the combined group) along with a 10 mg placebo pill taken 10-30 minutes before bedtime each nig
sham tDCS + ZOL:The participants will receive sham tDCS treatment (the stimulator will be turned off after 30 seconds of electrical stimulation, with the output current ramping up and down gradually d
Sponsors
The Affiliated Hospital of Yangzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years; 2. Diagnosis of chronic primary insomnia according to the International Classification of Sleep Disorders-third edition (ICSD-3); 3. Insomnia lasting >= 6 months with a Pittsburgh Sleep Quality Index (PSQI) score >7, and meeting either of the following criteria: a) an inadequate response to both at least one full course of cognitive behavioral therapy for insomnia (CBT-I) and at least one pharmacological treatment for >= 3 months; b) an inadequate response after pharmacological treatment with at least two types of medications with distinct mechanisms of action for >= 3 months ; 4. Voluntary participation in this study and signed informed consent; 5. Agreeing not to take other pharmacological or nonpharmacological treatment during the whole trial.
Exclusion criteria
Exclusion criteria: 1. Craniocerebral or scalp injury; 2. Combine severe neurological or mental disorders; 3. Doing night shift work; 4. Prior exposure to electrocon vulsive therapy, transcranial magnetic stimulation, or transcranial current stimulation; 5. With any metal implants in the body, claustrophobia, or any other reasons that would prevent an MRI 6. Being pregnant or lactating; 7. Known hypersensitivity to trial-related medications; 8. History of drug or alcohol abuse/dependence; 9. Participation in concurrent clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rates (Definition of response rate: the proportion of patients whose PSQI scores decrease by >= 50% after treatment compared with the baseline); | — |
Secondary
| Measure | Time frame |
|---|---|
| response rates;clinical remission;PSQI;ISI;Sleep smart wearable device;Hamilton Anxiety Scale,Hamilton Depression Scale;brain functional magnetic resonance imaging; | — |
Countries
China
Contacts
Public ContactLuo Zhang
The Affiliated Hospital of Yangzhou University
Outcome results
None listed