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A single-center, open-label exploratory clinical trial for multi-target electrical stimulation of brain in the treatment of refractory depression and cardiac neurosis

A single-center, open-label exploratory clinical trial for multi-target electrical stimulation of brain in the treatment of refractory depression and cardiac neurosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034340
Enrollment
Unknown
Registered
2020-07-02
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

Refractory depression and cardiac neurosis

Interventions

intractable epilepsy and depression evaluated preoperatively with intracranial electrode implantation group verssus intractable epilepsy and cardiac neurosis who underwent preoperative assessment with

Sponsors

Xuanwu Hospital of Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients with intractable epilepsy and depression who underwent preoperative assessment with intracranial electrodes implantation 1. For patients who meet the diagnostic criteria of refractory epilepsy, intracranial electrodes were implanted for preoperative evaluation, and the implanted brain targets covered dorsolateral prefrontal lobe, lateral orbitofrontal gyrus, insular lobe or amygdala; 2. At the time of enrollment, it was confirmed by at least two attending physicians and above, which met the diagnostic criteria for major depressive disorder depressive episode in the diagnostic and Statistical Manual of mental disorders (DSM-V); 3. The total score of Hamilton Depression Rating scale-17 (HDRS-17) was more than or equal to 17 at the time of inclusion; 4. Aged 18-55 years old; 5. Right handed patients; 6. Patients who agree and sign informed consent. Inclusion criteria for patients with intractable epilepsy and cardiac dysfunction who underwent preoperative assessment with intracranial electrodes implantation 1. For patients who meet the diagnostic criteria of refractory epilepsy, intracranial electrodes were implanted for preoperative evaluation, and the implanted brain targets covered dorsolateral prefrontal lobe, lateral orbitofrontal gyrus, insular lobe or amygdala; 2. Clinical symptoms: palpitation, dyspnea, precordial pain, autonomic nerve dysfunction, etc. patients have strong subjective feelings, which affect the quality of life of patients; 3. Signs: lack of positive signs with important pathological significance (there may be slight increase of blood pressure, acceleration or deceleration of heart rate, etc.); 4. Auxiliary examination: lack of definite abnormal changes with important pathological significance (sinus tachycardia or bradycardia); 5. Aged 18-55 years old; 6. Right handed patients; 7. Patients who agree and sign informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria for patients with intractable epilepsy and depression evaluated preoperatively with intracranial electrode implantation: 1. Patients with other psychotic disorders such as bipolar disorder; 2. Patients with alcohol and psychotropic substances abuse / dependence; 3. Patients with high risk of serious impulsivity, suicidal tendency or self injury, with score of HDRS-17 item 3 (suicide) = 3; 4. Patients with severe or unstable organic diseases; 5. Patients with frequent seizures; 6. The researcher thinks that there is an inappropriate situation to participate in this study. Exclusion criteria for patients with intractable epilepsy and cardiac neurosis who underwent preoperative assessment with intracranial electrodes 1. Organic heart diseases such as coronary atherosclerotic heart disease, mitral valve prolapse syndrome, myocarditis, etc; 2. Patients with severe or unstable organic diseases; 3. Patients with frequent seizures; 4. The researcher thinks that there is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
mood state;Neuropsychological scale;Heart rate related indicators;

Secondary

MeasureTime frame
electroencephalogram;Magnetic resonance;

Countries

China

Contacts

Public ContactWu Liyong

Xuanwu Hospital of Capital Medical University

wmywly@hotmail.com+86 13683120871

Outcome results

None listed

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