Neural Mechanisms With CES in Depression

Depression Clinical Trial

Official title:

Understanding Neural Mechanisms Associated With Cranial Electrotherapy Stimulation in Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04587531
• Other study ID #: UK-MDDEEG
• Status: Terminated
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: July 17, 2023

Study information

• Verified date: November 2023
• Source: Electromedical Products International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The aim is to understand if there would be changes in the neural signals following CES.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 17, 2023
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Cranial Electrotherapy Stimulation
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.

Locations

Country	Name	City	State
United Kingdom	Oxford Brooke University	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Electromedical Products International, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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