Neural Mechanisms With CES in Depression

March 21, 2023 updated by: Electromedical Products International, Inc.

Understanding Neural Mechanisms Associated With Cranial Electrotherapy Stimulation in Depression

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active CES Therapy
Group receives active treatment for 6 weeks. The intervention used will be cranial electrotherapy stimulation from and Alpha-Stim AID.
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.
Other Names:
  • Alpha-Stim
Sham Comparator: Sham CES Therapy
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
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.
Other Names:
  • Alpha-Stim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Electroencephalogram (EEG) pre-and post-treatment
Time Frame: Pre-treatment; 1 month, 3 months, and 6 months 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
Time Frame: Week 1 and Week 6
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
Time Frame: Week 1 and Week 6
Clinician rated standardized measure of depression with scores ranging from 0-50, with higher scores indicating more severe depression.
Week 1 and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Electromedical Products International, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UK-MDDEEG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study results will be available via published article. Individual data will be kept confidential by primary investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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