Epilepsy，Cognition
Conditions
Brief summary
Epilepsy is one of the common chronic diseases of the central nervous system. 30% to 40% of patients with epilepsy have varying degrees of cognitive impairment, which affects their quality of life. At present, the treatment of cognitive impairment in patients with epilepsy is relatively scarce, and the therapeutic effect is still not ideal. Recent studies have shown that sleep disorder is also an important factor causing cognitive dysfunction, and improving sleep quality has a prospect to become a new way to treat cognitive impairment in patients with epilepsy. The purpose of this study is to observe the relationship between sleep and cognitive function in patients with epilepsy, and to improve the sleep quality of patients with epilepsy, so as to provide new ideas for improving cognitive impairment in patients with epilepsy.
Interventions
OTHERMelatonin Tablets
Melatonin Tablets was given 3 tablets (6.21mg) daily at the beginning of bedtime at night for a total of 4 weeks.
OTHERLactasin Tablets
The placebo group was given at the beginning of bedtime at night for a total of 4 weeks.
DEVICEtranscutaneous vagus nerve stimulation
transcutaneous vagus nerve stimulation treatment, frequency 10Hz, stimulation site is the anterior wall of the left external auditory canal (tragus), used twice a day, each treatment for 30 minutes, a total of 4 weeks.
In the sham stimulation group, the stimulation site was the left earlobe with a frequency of 10Hz, which was used twice a day for 30 minutes for a total of 4 weeks.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
7 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. In accordance with the diagnostic criteria of epilepsy; 2. History of epilepsy ≥ 1 year; 3. Epilepsy with cognitive impairment; 4. Age 7-65 years old; 5. There was no change in the type and dose of antiepileptic drugs during the experiment; 6. Patients and their families were aware of this study and signed an informed consent form.
Exclusion criteria
* 1\. Status epilepticus; 2. Complicated with severe infection, cerebrovascular diseases, malignant tumors, other nervous system diseases, and systemic diseases that can involve the nervous system (such as immune diseases, etc.), serious dysfunction of heart, liver, kidney and other organs; 3. Non-epileptic seizures such as syncope and hysteria; 4. Women during lactation or pregnancy; 5. Combined use of sleeping and sedative drugs; 6. There are contraindications of melatonin and percutaneous vagal nerve stimulation (tVNS).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment | Week 4 | The difference between the end of treatment score and the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rey auditory verbal learning test | Week 4 | The difference between the end of treatment score and the baseline |
| Boston naming test | Week 4 | The difference between the end of treatment score and the baseline |
| Rey complex figure test | Week 4 | The difference between the end of treatment score and the baseline |
| Wechsler Memory Scale | Week 4 | The difference between the end of treatment score and the baseline |
| Pittsburgh sleep quality index | Week 4 | The difference between the end of treatment score and the baseline |
| Quality of life questionnaire in epilepsy inventory | Week 4 | The difference between the end of treatment score and the baseline |
Countries
China
Contacts
Primary ContactLei Ma, associate professor
Outcome results
None listed