Neural Mechanisms With CES in Depression

NCT04587531 | Terminated FDA Device

• 1 other identifier: UK-MDDEEG
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; EEG; Cranial Electrotherapy Stimulation (CES); Alpha-Stim

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Active CES Therapy

ACTIVE COMPARATOR

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

Device: Cranial Electrotherapy Stimulation

Sham CES Therapy

SHAM COMPARATOR

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

Interventions

Cranial Electrotherapy Stimulation DEVICE

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.

Also known as: Alpha-Stim

Active CES Therapy; Sham CES Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Electromedical Products International, Inc.: lead

Study Sites (1)

Oxford Brooke University

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Sanjay Kumar, PhD

  Oxford Brooke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Treatment device will deliver subsensory treatment while the sham device will deliver no treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: July 5, 2021
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)