Neural Mechanisms With CES in Depression

Electromedical Products International

Status: Terminated

Conditions: Depression

Treatments: Device: Cranial Electrotherapy Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04587531

UK-MDDEEG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1 participants in 2 patient groups

Active CES Therapy

Active Comparator group

Description:

Group receives active treatment for 6 weeks. The intervention used will be cranial electrotherapy stimulation from and Alpha-Stim AID.

Treatment:

Device: Cranial Electrotherapy Stimulation

Sham CES Therapy

Sham Comparator group

Description:

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.

Treatment:

Device: Cranial Electrotherapy Stimulation