DepressionNCT04587531
Neural Mechanisms With CES in Depression
A study testing Cranial Electrotherapy Stimulation in people with Depression, run by Electromedical Products International, Inc. at 1 site in United Kingdom.
Trial summary
This study will examine the effect of cranial electrotherapy stimulation (CES) treatment on adults with depression. Scalp based electroencephalogram (EEG) will be utilized to record the brain activity of participants whilst they perform computer based tasks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Cranial Electrotherapy Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jul 2021to 17 Jul 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18 to 65 years of age.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- Subjects must fulfil ICD-10 criteria for Depressive Episode or Recurrent Depressive Disorders based on clinical assessment and confirmed by short a structured diagnostic interview, MINI.
- Subjects must have an initial score of at least 14 on the BDI at screen and at baseline of study.
- Current depressive episode of at least 4 weeks duration.
Who cannot join
- Current or past diagnosis of any other major mental disorders (e.g., schizophrenia, bipolar affective disorders)
- Depression with psychotic symptoms
- Dysthymia
- Depression of organic origin
- Substance misuse/ dependence
- Subjects with one or more seizures without a clear and resolved etiology.
- Female subjects who are pregnant.
- Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Neural Mechanisms Associated With Cranial Electrotherapy Stimulation in Depression
This study will examine the effect of cranial electrotherapy stimulation (CES) treatment on adults with depression. Scalp based electroencephalogram (EEG) will be utilized to record the brain activity of participants whilst they perform computer based tasks. The aim is to understand if there would be changes in the neural signals following CES.
Read the detailed description
Patients meeting the inclusion and exclusion criteria and volunteer to participate will be randomly assigned to "Active CES Therapy" and "Sham CES Therapy" groups. Before start of the treatment (active or sham), their medication details or any other form of treatment they are on will be noted down. These patients will be assessed on self-rated Beck Depression Inventory and clinician rated Hamilton Depression Rating Scale. They will be also assessed on neuropsychological functions of attention, executive functions, memory, information processing and emotional processing evaluation using Emotional Test Battery. In addition, 25 patients from each group will undergo EEG recording whilst they perform computer based tasks. These assessments will take place at 4 time points (Pre-treatment, 1 month after treatment, at 3 months, and at 6 months after treatment).
The study will use scalp based electroencephalogram (EEG) to record the brain activity of participants whilst they perform computer based tasks. The aim is to understand if there would be changes in the neural signals following cranial electrotherapy stimulation. Investigators propose to use EEG to investigate if CES therapy will modulate brain responses in a way that leads to better information processing as a mechanism to improve depression. Furthermore, researchers will also investigate changes in EEG based brain connectivity patterns following CES therapy. Therefore, as a mechanism of action for CES therapy could be changes in the functional brain connectivity for efficient information processing. EEG investigation will be helpful to understand this connectivity based mechanism following CES.
- Conditions
- Depression
- Being tested
- Cranial Electrotherapy Stimulation
- Keywords
- Depression, EEG, Cranial Electrotherapy Stimulation (CES), Alpha-Stim
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial Electrotherapy StimulationDevice
Also called Alpha-Stim
Alpha-Stim® AID microcurrent and cranial electrotherapy stimulator will be used. Daily one hour cranial electrotherapy stimulation (CES) treatment using ear clip electrodes with current set at fixed level of 100 uA (a subsensory current level), 0.5 Hertz will be used for active CES treatment group for 6 weeks. For the sham group the Alpha-Stim® AID ear clips will not emit electricity.
| Study group | Role | What they receive |
|---|---|---|
| Active CES Therapy | Active comparator | Group receives active treatment for 6 weeks. The intervention used will be cranial electrotherapy stimulation from and Alpha-Stim AID. Receives: Device: Cranial Electrotherapy Stimulation |
| Sham CES Therapy | Sham comparator | Group receives treatment using sham cranial electrotherapy stimulation devices for 6 weeks. No actual treatment will be received. This group will not receive any treatment interventions. The same outcome measures will be used as the treatment group. Receives: Device: Cranial Electrotherapy Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Electroencephalogram (EEG) pre-and post-treatment
Scalp based EEG to measure changes in neural signals
Measured: Pre-treatment; 1 month, 3 months, and 6 months post-treatment
Change in Beck Depression Inventory score
Self-report standardized measure of depression with scores ranging from 0-63 with higher scores indicating more severe depression.
Measured: Week 1 and Week 6
Change in Hamilton Depression Rating Scale
Clinician rated standardized measure of depression with scores ranging from 0-50, with higher scores indicating more severe depression.
Measured: Week 1 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start5 Jul 2021
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Why it stopped: Lack of financing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 6-week, randomized, double-blind, placebo controlled evaluation of efficacy and tolerability of cranial electrotherapy stimulation (CES) for the treatment of adults with depression. EEG readings will evaluate changes in neural signals following CES treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Electromedical Products International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanjay Kumar, PhD, Principal investigator, Oxford Brooke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587531
- Sponsor's protocol ID
- UK-MDDEEG
- Status last verified
- Nov 2023
- First submitted
- 7 Oct 2020
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study results will be available via published article. Individual data will be kept confidential by primary investigator
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Neural Mechanisms Associated With Cranial Electrotherapy Stimulation in Depression
- ClinicalTrials.gov ID
- NCT04587531
- Acronym / sponsor ID
- UK-MDDEEG
- Conditions
- Depression
- Keywords
- Depression, EEG, Cranial Electrotherapy Stimulation (CES), Alpha-Stim
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of financing
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Electromedical Products International, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 14 Oct 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.
This study will examine the effect of cranial electrotherapy stimulation (CES) treatment on adults with depression. Scalp based electroencephalogram (EEG) will be utilized to record the brain activity of participants whilst they perform computer based tasks. The aim is to understand if there would be changes in the neural signals following CES.
Detailed description
Patients meeting the inclusion and exclusion criteria and volunteer to participate will be randomly assigned to "Active CES Therapy" and "Sham CES Therapy" groups. Before start of the treatment (active or sham), their medication details or any other form of treatment they are on will be noted down. These patients will be assessed on self-rated Beck Depression Inventory and clinician rated Hamilton Depression Rating Scale. They will be also assessed on neuropsychological functions of attention, executive functions, memory, information processing and emotional processing evaluation using Emotional Test Battery. In addition, 25 patients from each group will undergo EEG recording whilst they perform computer based tasks. These assessments will take place at 4 time points (Pre-treatment, 1 month after treatment, at 3 months, and at 6 months after treatment).
The study will use scalp based electroencephalogram (EEG) to record the brain activity of participants whilst they perform computer based tasks. The aim is to understand if there would be changes in the neural signals following cranial electrotherapy stimulation. Investigators propose to use EEG to investigate if CES therapy will modulate brain responses in a way that leads to better information processing as a mechanism to improve depression. Furthermore, researchers will also investigate changes in EEG based brain connectivity patterns following CES therapy. Therefore, as a mechanism of action for CES therapy could be changes in the functional brain connectivity for efficient information processing. EEG investigation will be helpful to understand this connectivity based mechanism following CES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A 6-week, randomized, double-blind, placebo controlled evaluation of efficacy and tolerability of cranial electrotherapy stimulation (CES) for the treatment of adults with depression. EEG readings will evaluate changes in neural signals following CES treatment.
| Arm | Type | Receives |
|---|---|---|
| Active CES Therapy | Active comparator | Device: Cranial Electrotherapy StimulationGroup receives active treatment for 6 weeks. The intervention used will be cranial electrotherapy stimulation from and Alpha-Stim AID. |
| Sham CES Therapy | Sham comparator | Device: Cranial Electrotherapy StimulationGroup receives treatment using sham cranial electrotherapy stimulation devices for 6 weeks. No actual treatment will be received. This group will not receive any treatment interventions. The same outcome measures will be used as the treatment group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects, 18 to 65 years of age.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- Subjects must fulfil ICD-10 criteria for Depressive Episode or Recurrent Depressive Disorders based on clinical assessment and confirmed by short a structured diagnostic interview, MINI.
- Subjects must have an initial score of at least 14 on the BDI at screen and at baseline of study.
- Current depressive episode of at least 4 weeks duration.
Key exclusion criteria (8 listed)
- Current or past diagnosis of any other major mental disorders (e.g., schizophrenia, bipolar affective disorders)
- Depression with psychotic symptoms
- Dysthymia
- Depression of organic origin
- Substance misuse/ dependence
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 |
|---|---|---|
| Cranial Electrotherapy StimulationAlso: Alpha-StimAlpha-Stim® AID microcurrent and cranial electrotherapy stimulator will be used. Daily one hour cranial electrotherapy stimulation (CES) treatment using ear clip electrodes with current set at fixed level of 100 uA (a subsensory current level), 0.5 Hertz will be used for active CES treatment group for 6 weeks. For the sham group the Alpha-Stim® AID ear clips will not emit electricity. | Device | Active CES Therapy, Sham CES Therapy |
Primary outcome
Change in Electroencephalogram (EEG) pre-and post-treatment
Time frame: Pre-treatment; 1 month, 3 months, and 6 months post-treatment
Scalp based EEG to measure changes in neural signals
Change in Beck Depression Inventory score
Time frame: Week 1 and Week 6
Self-report standardized measure of depression with scores ranging from 0-63 with higher scores indicating more severe depression.
Change in Hamilton Depression Rating Scale
Time frame: Week 1 and Week 6
Clinician rated standardized measure of depression with scores ranging from 0-50, with higher scores indicating more severe depression.
Results and safety
The study was stopped early (reason given: Lack of financing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No. Study results will be available via published article. Individual data will be kept confidential by primary investigator
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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.
Sanjay Kumar, PhD principal investigator
Oxford Brooke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Electrotherapy Stimulation in people with Depression, run by Electromedical Products International, Inc. at 1 site in United Kingdom.
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 5 inclusion and 8 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 24 Nov 2023. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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: Lack of financing). 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?
Change in Electroencephalogram (EEG) pre-and post-treatment (time frame: Pre-treatment; 1 month, 3 months, and 6 months post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2023.