CESNCT04465136
CES in the Elderly With Generalized Anxiety Disorders
A study testing CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA) in people with CES and Anxiety Disorders and Symptoms, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- CES, Anxiety Disorders and Symptoms
- What is being tested?
- CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Feb 2021to 28 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Cerebrovascular diseases
- Arrhythmia or with pacemaker implantation
- Used to receive brain stimulation therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cranial Electrotherapy Stimulation as Adjunctive Therapy on Anxiety Disorder in Elderly: an Open-label, Pilot 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.
Read the 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
- Being tested
- CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Received CES intervention | Experimental | CES with the frequency of 0.5 Hertz; current of 100~600micro-ampere, for 60 minutes, everyday for 6 weeks, total 42 sessions intervention Receives: Device: CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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 outcomes (4)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start19 Feb 2021
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
Why it stopped: 1\. The results showed significant improvement after CES; 2. Run out of study grant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CESStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Che-Sheng Chu, Kaohsiung Veterans General Hospital.
- Investigators
- Che-Sheng Chu, MD, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465136
- Sponsor's protocol ID
- Kaohsiung VGH
- Status last verified
- Dec 2022
- First submitted
- 27 Mar 2020
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22741094Schroeder 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.
PubMed 11682346Barclay 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.
PubMed 24856571Morriss 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.
PubMed 31103808Yennurajalingam 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.
PubMed 28870799Shekelle 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/
PubMed 29630193
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cranial Electrotherapy Stimulation as Adjunctive Therapy on Anxiety Disorder in Elderly: an Open-label, Pilot Study
- ClinicalTrials.gov ID
- NCT04465136
- Acronym / sponsor ID
- Kaohsiung VGH
- Conditions
- CES, Anxiety Disorders and Symptoms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 1\. The results showed significant improvement after CES; 2. Run out of study grant.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Received CES intervention | Experimental | Device: CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA)CES with the frequency of 0.5 Hertz; current of 100~600micro-ampere, for 60 minutes, everyday for 6 weeks, total 42 sessions intervention |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Received CES intervention |
Primary outcome
The change of objective anxiety symptom from baseline
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
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
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
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.
4 secondary outcomes
The change of objective depressive symptom from baseline
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
The change of subjective depressive symptom from baseline
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
The change of quality of life from baseline: Brief version of World Health Organization Quality of Life questionnaire (WHOQOL-BREF)
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
The change of quality of sleep from baseline: Pittsburgh Sleep Quality Index (PSQI)
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
Results and safety
The study was stopped early (reason given: 1\. The results showed significant improvement after CES; 2. Run out of study grant.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Background: PubMed 22741094Feusner 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.
- Background: PubMed 11682346Schroeder 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.
- Background: PubMed 24856571Barclay 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.
- Background: PubMed 31103808Morriss 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.
- Background: PubMed 28870799Yennurajalingam 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.
- Background: PubMed 29630193Shekelle 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/
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Che-Sheng Chu, MD principal investigator
Kaohsiung Veterans General Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA) in people with CES and Anxiety Disorders and Symptoms, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 1\. The results showed significant improvement after CES; 2. Run out of study grant.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of objective anxiety symptom from baseline (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04465136, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.