Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
In this project, the efficacy of different tDCS protocols in major depression will be investigated. The tDCS protocols have already been investigated in humans, and results showed that stimulation intensity has a different effect on tDCS long-term aftereffects based on the human motor cortex model. The project has three major goals: first, we want to see if the differential outcome of tDCS dosage, as present in healthy populations, can be translated to patients with major depression. Second, we want to compare the efficacy of a multi-channel novel protocol with conventional tDCS modules. Lastly, we are interested in the safety and tolerability of optimized multi-channel. The project output will be an optimized tDCS protocol for major depression treatment.

Official Title
-----------------
Optimizing tDCS Protocol for Clinical Use in Patients With Major Depressive Disorder

Conditions
-----------------
Depressive Disorder, Cognitive Impairment, Psychiatric Disorder

Intervention / Treatment
-----------------
* Device: transcranial direct current stimulation (tDCS)
* Device: multichannel transcranial direct current stimulation (tDCS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet DSM-5 criteria for a moderate-to-severe major depression, with Hamilton Rating Scale for Depression (HAMD) score of ≥14 and <24 administered by a psychiatrist. being 18-60 years old providing written informed consent If female, negative urine pregnancy test Treatment naïve or on a stable standard antidepressant regimen (including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclic's (TCAs)) with no change in treatment 6-weeks prior to and during the tDCS intervention Exclusion Criteria: smoker pregnancy alcohol or substance dependence history of seizure history of neurological disorder comorbid Schizophrenia Axis I disorder, bipolar disorder, substance abuse or dependence, dementia, personality disorder history of head injury currently receiving any form of Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, or Acceptance and Commitment Therapy Presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double-blind, parallel group trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional tDCS group<br>The conventional tDCS group will receive 30 session of 20-minute stimulation at 2 mA intensities using standard electrodes (7 x 5 cm) over the target region | Device: transcranial direct current stimulation (tDCS)<br>* In tDCS, direct electrical currents at the intensity of interest (2 mA for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm) or via more than two but smaller round electrodes over the target regions.<br>|
| Active Comparator: multi-channel tDCS group<br>The multi-channel tDCS group will receive 30 session of 20-minute stimulation at 2 mA intensities using 8 electrodes (2.5 x 2.5 cm) over the target region | Device: multichannel transcranial direct current stimulation (tDCS)<br>* In multichannel tDCS, direct electrical currents at the intensity of interest (2 mA for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through more than two and smaller round electrodes over the target regions.<br>|
| Placebo Comparator: sham tDCS group<br>The conventional tDCS group will receive 30 session of 20-minute placebo stimulation using standard electrodes (7 x 5 cm) over the target region | Device: transcranial direct current stimulation (tDCS)<br>* In tDCS, direct electrical currents at the intensity of interest (2 mA for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm) or via more than two but smaller round electrodes over the target regions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depressive symptoms | the score on the Beck Depression Inventory (BDI-II). The BDI is a self-reported twenty-one questions about how the subject has been feeling in the last week, and each question has four answers ranging in intensity. Scoring 19 or higher on the BDI-II is considered moderate depression | up to 3 months after the intervention | 
| depressive symptoms | the score on the Hamilton Depression Rating Scale (HDRS). The HDRS is a multiple-item questionnaire designed for measuring adult depression and is administered by health care professionals. It is currently the most common depression measure used worldwide. Items on the HDRS are scored from 0 to 4 or 0 to 2 depending on the symptom assessed, with high scores indicating greater symptom pathology. scores typically ranging from 15 to 20 indicate a clinical level of depressive symptomatology | up to 3 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Working memory task | Performance in the Spatial Working Memory (SWM) task, which is a recommended test for depression by Cambridge Cognition (CANTAB) | up to 1 month after the intervention | 
| Attention task | Performance in the Rapid Visual Information Processing (RVP) task, which is a recommended test for depression by Cambridge Cognition (CANTAB) | up to 1 month after the intervention | 
| Emotion Recognition Task | Performance in the Emotion Recognition Task (ERT), which is a recommended test for depression by Cambridge Cognition (CANTAB) | up to 1 month after the intervention | 
| electroencephalogram (EEG) functional connectivity | Change in the EEG functional connectivity in the frontal areas | up to 1 week after the intervention | 
| electroencephalogram (EEG) power | Change in the EEG alpha/theta/gamma power | up to 1 week after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tDCS, major depressive disorder