Depression
Conditions
Keywords
Depression, EEG, Cranial Electrotherapy Stimulation (CES), Alpha-Stim
Brief 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. 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.
Interventions
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.
Sponsors
Electromedical Products International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Treatment device will deliver subsensory treatment while the sham device will deliver no treatment.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Electroencephalogram (EEG) pre-and post-treatment | 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 | 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 | Week 1 and Week 6 | Clinician rated standardized measure of depression with scores ranging from 0-50, with higher scores indicating more severe depression. |
Countries
United Kingdom
Outcome results
None listed