Insomnia after stroke due to deficiency of both heart and spleen
Conditions
Interventions
The Western medicine group:Zopiclone tablets for oral administration
Transcranial Magnetic Stimulation Group:Transcranial Magnetic Stimulation Therapy
Traditional Chinese Medicine combined with Transcranial Magnetic Stimulation Group:Traditional Chinese medicine combined with low-frequency transcranial magnetic therapy
Sponsors
Fujian University of Traditional Chinese Medicine Affiliated Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The patient meets the diagnostic criteria for ischemic stroke or cerebral hemorrhage as listed in this study, and also meets the diagnostic criteria for insomnia as stipulated in the "2017 Chinese Guidelines for Diagnosis and Treatment of Adult Insomnia", as well as the diagnostic criteria for "stroke disease" and "insomnia disease" in traditional Chinese medicine, and conforms to the diagnostic standard of "deficiency of heart and spleen", and this stroke is the first occurrence; (2) The insomnia symptoms occurred after the stroke, and the duration of the stroke was from 14 days to 180 days; (3) The age is between 40 and 75 years old; (4) There is no obvious cognitive impairment or speech disorder, and no severe mental disorder occurred before the stroke; (5) The patient did not take any related sedative and sleep medication or receive other related treatments before the stroke; (6) Before the stroke, there were no serious diseases of the heart, liver, kidney, etc., and the condition after the stroke was stable with no serious complications; (7) There is no history of acute or chronic pain; (8) The total score of PSQI is > 7; (9) The patient and/or the family member agrees and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who have experienced more than one stroke; (2) Patients with obvious cognitive impairments after stroke and unable to cooperate with scale assessment; (3) Patients with severe mental disorders and anxiety depression; (4) Patients currently taking diazepam, antidepressants, antipsychotic drugs, etc.; (5) Patients with unstable vital signs, accompanied by severe complications (pulmonary infection, renal failure, etc.), and those who are intolerant; (6) Patients with contraindications for transcranial magnetic stimulation treatment or who are not suitable for transcranial magnetic stimulation treatment, such as those with a history of epilepsy or high risk of epilepsy, intracranial metal implants, aneurysm clips, artificial cochlear implants, deep brain stimulators, cardiac pacemakers, implanted defibrillators, drug pumps and other implanted electronic devices, or those judged by the researcher to be unsuitable for transcranial magnetic stimulation treatment; (7) Pregnant or lactating women, or those planning to become pregnant during the study period; (8) Patients who are allergic to the drug components used in this study, or have a previous history of severe drug allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Scoring Scale;Activities of Daily Living Assessment Scale;Polysomnographic Indices; | — |
Countries
CHINA
Contacts
Public ContactSaie Huang
Fujian University of Traditional Chinese Medicine Affiliated Rehabilitation Hospital
Outcome results
None listed