NCT04587531

Neural Mechanisms With CES in Depression

Understanding Neural Mechanisms Associated With Cranial Electrotherapy Stimulation in Depression

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Electromedical Products International, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-05
• Primary completion: 2023-07-17
• Completion: 2023-07-17
• First posted: 2020-10-14
• Last updated: 2023-11-24

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study