Neural Mechanisms With CES in Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Understanding Neural Mechanisms Associated With Cranial Electrotherapy Stimulation in Depression

Conditions
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Depression

Intervention / Treatment
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* Device: Cranial Electrotherapy Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active CES Therapy<br>Group receives active treatment for 6 weeks. The intervention used will be cranial electrotherapy stimulation from and Alpha-Stim AID. | Device: Cranial Electrotherapy Stimulation<br>* 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.<br>* Other names: Alpha-Stim;|
| Sham Comparator: Sham CES Therapy<br>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. | Device: Cranial Electrotherapy Stimulation<br>* 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.<br>* Other names: Alpha-Stim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Electroencephalogram (EEG) pre-and post-treatment | Scalp based EEG to measure changes in neural signals | 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. | 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. | Week 1 and Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, EEG, Cranial Electrotherapy Stimulation (CES), Alpha-Stim