NCT04465136

CES in the Elderly With Generalized Anxiety Disorders

The Effect of Cranial Electrotherapy Stimulation as Adjunctive Therapy on Anxiety Disorder in Elderly: an Open-label, Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Kaohsiung Veterans General Hospital. · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• CES
• Anxiety Disorders and Symptoms

Interventions

Type	Name	Description
DEVICE	CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA)	CES is a brain stimulation device with 2 electrodes on the bilateral earlobe. It uses Alternating current to stimulate the brain including thalamus, vagus nerve system and influence EEG and neurotransmitters like gamma-aminobutyrate. Stimulation was applied at a current intensity that can be adjusted continuously to provide between 10 and 600 micro-ampere and frequency of 0.5Hertz for 60 minutes, everyday for 6 weeks, total 42 sessions.

Timeline

• Start date: 2021-02-19
• Primary completion: 2022-11-28
• Completion: 2022-11-28
• First posted: 2020-07-09
• Last updated: 2022-12-14

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study