CES in the Elderly With Generalized Anxiety Disorders

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for CES

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Kaohsiung Veterans General Hospital.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Received CES intervention

Arm 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

Outcomes

Primary Outcome Measures

The change of objective anxiety symptom from baseline

evaluate the Hamilton Anxiety Rating Scale (HAM-A) for objective anxiety Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

The change of subjective anxiety symptom from baseline

evaluate the Beck anxiety inventory (BAI) for subjective anxiety The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are: 0-7: minimal anxiety; 8-15: mild anxiety; 16-25: moderate anxiety; 26-63: severe anxiety.

Secondary Outcome Measures

The change of objective depressive symptom from baseline

Evaluate the Hamilton Depression Rating Scale (HAM-D) for objective anxiety The Ham-D is the most widely used clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

The change of subjective depressive symptom from baseline

Evaluate the Beck depression inventory-II (BDI-II) for subjective anxiety the BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original: 0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression.

The change of quality of life from baseline: Brief version of World Health Organization Quality of Life questionnaire (WHOQOL-BREF)

Evaluate the "Brief version of World Health Organization Quality of Life questionnaire - Taiwan version" for quality of life. The WHOQOL-BREF produces a quality of life profile. It is possible to derive four domain scores. Each item is weighted on a 0-4 interval scale. The WHOQOL-BREF score is then calculated by totaling the 4 domain scores. The calculation method of the scores in a certain domain is: (summation of the scores in each domain) x 4 / (number of items in a category). The adjusted scores of each domain are as low as 4 points and as high as 20 points. The overall score ranges from 16 to 80, where higher scores denote a higher life quality.

The change of quality of sleep from baseline: Pittsburgh Sleep Quality Index (PSQI)

Evaluate the Pittsburgh Sleep Quality Index (PSQI) for quality of sleep Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

Full Information

NCT ID

NCT04465136

First Posted

March 27, 2020

Last Updated

December 12, 2022

Sponsor

Kaohsiung Veterans General Hospital.

1. Study Identification

Unique Protocol Identification Number

NCT04465136

Brief Title

CES in the Elderly With Generalized Anxiety Disorders

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Terminated

Why Stopped

1. The results showed significant improvement after CES; 2. Run out of study grant.

Study Start Date

February 19, 2021 (Actual)

Primary Completion Date

November 28, 2022 (Actual)

Study Completion Date

November 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaohsiung Veterans General Hospital.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CES, Anxiety Disorders and Symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Received CES intervention

Arm Type

Experimental

Arm 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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

The change of objective anxiety symptom from baseline

Description

evaluate the Hamilton Anxiety Rating Scale (HAM-A) for objective anxiety Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Time Frame

1.Change from baseline HAM-A score after the 4 weeks and the 6 weeks. 2.Change from baseline HAM-A score after 4 weeks (week 10) after the full CES treatment course

Title

The change of subjective anxiety symptom from baseline

Description

evaluate the Beck anxiety inventory (BAI) for subjective anxiety The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are: 0-7: minimal anxiety; 8-15: mild anxiety; 16-25: moderate anxiety; 26-63: severe anxiety.

Time Frame

1. Change from baseline BAI score after the 4 weeks and the 6 weeks. 2.Change from baseline BAI score after 4 weeks (week 10) after the full CES treatment course

Secondary Outcome Measure Information:

Title

The change of objective depressive symptom from baseline

Description

Evaluate the Hamilton Depression Rating Scale (HAM-D) for objective anxiety The Ham-D is the most widely used clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

Time Frame

1. Change from baseline HAM-D score after the 4 weeks and the 6 weeks. 2.Change from baseline HAM-D score after 4 weeks (week 10) after the full CES treatment course

Title

The change of subjective depressive symptom from baseline

Description

Evaluate the Beck depression inventory-II (BDI-II) for subjective anxiety the BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original: 0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression.

Time Frame

1. Change from baseline BDI-II score after the 4 weeks and the 6 weeks. 2.Change from baseline BDI-II score after 4 weeks (week 10) after the full CES treatment course

Title

The change of quality of life from baseline: Brief version of World Health Organization Quality of Life questionnaire (WHOQOL-BREF)

Description

Evaluate the "Brief version of World Health Organization Quality of Life questionnaire - Taiwan version" for quality of life. The WHOQOL-BREF produces a quality of life profile. It is possible to derive four domain scores. Each item is weighted on a 0-4 interval scale. The WHOQOL-BREF score is then calculated by totaling the 4 domain scores. The calculation method of the scores in a certain domain is: (summation of the scores in each domain) x 4 / (number of items in a category). The adjusted scores of each domain are as low as 4 points and as high as 20 points. The overall score ranges from 16 to 80, where higher scores denote a higher life quality.

Time Frame

1. Change from baseline WHOQOL-BREF score after the 4 weeks and the 6 weeks. 2.Change from baseline WHOQOL-BREF score after 4 weeks (week 10) after the full CES treatment course

Title

The change of quality of sleep from baseline: Pittsburgh Sleep Quality Index (PSQI)

Description

Evaluate the Pittsburgh Sleep Quality Index (PSQI) for quality of sleep Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

Time Frame

1. Change from baseline PSQI score after the 4 weeks and the 6 weeks. 2.Change from baseline PSQI score after 4 weeks (week 10) after the full CES treatment course

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Che-Sheng Chu, MD

Organizational Affiliation

Kaohsiung Veterans General Hospital.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaohsiung Veterans General Hospital.

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

22741094

Citation

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.

Results Reference

background

PubMed Identifier

11682346

Citation

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.

Results Reference

background

PubMed Identifier

24856571

Citation

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.

Results Reference

background

PubMed Identifier

31103808

Citation

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.

Results Reference

background

PubMed Identifier

28870799

Citation

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.

Results Reference

background

PubMed Identifier

29630193

Citation

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/

Results Reference

background

CES, Anxiety Disorders and Symptoms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial