CES in the Elderly With Generalized Anxiety Disorders

Kaohsiung Veterans General Hospital

Status: Terminated

Conditions: Anxiety Disorders and Symptoms; CES

Treatments: Device: CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04465136

Kaohsiung VGH

Details and patient eligibility

About

The study aimed to investigate whether cranial electrotherapy stimulation(CES) could benefit anxiety symptoms, depressive symptoms, quality of sleep and quality of life in elderly patients with anxiety disorder.

Full description

Several studies have shown cranial electrotherapy stimulation (CES) could decrease depression and anxiety symptoms in patients with mood disorder. However, none study so far focused on the elderly population to investigate the anti-depressant and anxiolytic effect in elderly patient with anxiety disorder. Hence, this pilot study aims to assess the safety and efficacy of CES on anxiety symptoms, depressive symptoms, sleep quality and life quality in elderly patient with anxiety disorder. The study was an open-label, one arm study. The study aimed to investigate whether cranial electrotherapy stimulation(CES) could benefit anxiety symptoms, depressive symptoms, quality of sleep and quality of life in elderly patients with anxiety disorder.

Enrollment: 27 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 60 to 85 years old
• Anxiety disorder confirmed by Mini-international neuropsychiatric interview (MINI)
• HAM-A score greater than 17 points
• HAM-D score lower than 17 points
• Mini-mental state examination score of 24 or more
• No psychiatric medication adjustment within 3 months.

Exclusion criteria

• Comorbid with another axis I psychiatric disorder, like schizophrenia, substance use disorder or other major mental illness screened by Mini-international neuropsychiatric interview (MINI)
• Contraindications for CES
• Implanted brain medical devices or mental in the head
• History of seizures
• History of intracranial neoplasm or surgery
• Severe head injuries
• Cerebrovascular diseases
• Arrhythmia or with pacemaker implantation
• Used to receive brain stimulation therapy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Received CES intervention

Experimental group

Description:

CES with the frequency of 0.5 Hertz; current of 100\~600micro-ampere, for 60 minutes, everyday for 6 weeks, total 42 sessions intervention

Treatment:

Device: CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA)