Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
27 participants
INTERVENTIONAL
2021-02-19
2022-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Received CES intervention
CES with the frequency of 0.5 Hertz; current of 100\~600micro-ampere, for 60 minutes, everyday for 6 weeks, total 42 sessions intervention
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
85 Years
ALL
No
Sponsors
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Kaohsiung Veterans General Hospital.
OTHER
Responsible Party
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Che-Sheng Chu
Department of Psychiatry, MD, attending physician
Principal Investigators
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Che-Sheng Chu, MD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Veterans General Hospital.
Locations
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Kaohsiung Veterans General Hospital.
Kaohsiung City, , Taiwan
Countries
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References
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Feusner JD, Madsen S, Moody TD, Bohon C, Hembacher E, Bookheimer SY, Bystritsky A. Effects of cranial electrotherapy stimulation on resting state brain activity. Brain Behav. 2012 May;2(3):211-20. doi: 10.1002/brb3.45.
Schroeder MJ, Barr RE. Quantitative analysis of the electroencephalogram during cranial electrotherapy stimulation. Clin Neurophysiol. 2001 Nov;112(11):2075-83. doi: 10.1016/s1388-2457(01)00657-5.
Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. 2014 Aug;164:171-7. doi: 10.1016/j.jad.2014.04.029. Epub 2014 Apr 21.
Morriss R, Xydopoulos G, Craven M, Price L, Fordham R. Clinical effectiveness and cost minimisation model of Alpha-Stim cranial electrotherapy stimulation in treatment seeking patients with moderate to severe generalised anxiety disorder. J Affect Disord. 2019 Jun 15;253:426-437. doi: 10.1016/j.jad.2019.04.020. Epub 2019 Apr 15.
Yennurajalingam S, Kang DH, Hwu WJ, Padhye NS, Masino C, Dibaj SS, Liu DD, Williams JL, Lu Z, Bruera E. Cranial Electrotherapy Stimulation for the Management of Depression, Anxiety, Sleep Disturbance, and Pain in Patients With Advanced Cancer: A Preliminary Study. J Pain Symptom Manage. 2018 Feb;55(2):198-206. doi: 10.1016/j.jpainsymman.2017.08.027. Epub 2017 Sep 21.
Shekelle P, Cook I, Miake-Lye IM, Mak S, Booth MS, Shanman R, Beroes JM. The Effectiveness and Risks of Cranial Electrical Stimulation for the Treatment of Pain, Depression, Anxiety, PTSD, and Insomnia: A Systematic Review [Internet]. Washington (DC): Department of Veterans Affairs (US); 2018 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK493132/
Other Identifiers
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Kaohsiung VGH
Identifier Type: -
Identifier Source: org_study_id