Clinical trial NCT04587531: Neural Mechanisms With CES in Depression
Official title: Understanding Neural Mechanisms Associated With Cranial Electrotherapy Stimulation in Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: Depression
EEG
Cranial Electrotherapy Stimulation (CES)
Alpha-Stim
Lead sponsor: Electromedical Products International, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Electroencephalogram (EEG) pre-and post-treatment
timeFrame: Pre-treatment; 1 month, 3 months, and 6 months post-treatment
measure: Change in Beck Depression Inventory score
timeFrame: Week 1 and Week 6
measure: Change in Hamilton Depression Rating Scale
timeFrame: Week 1 and Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Brooke University
Study officials:
affiliation: Oxford Brooke University
name: Sanjay Kumar, PhD
role: PRINCIPAL_INVESTIGATOR
References: