Clinical trial NCT06165445: Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder
Official title: Optimizing tDCS Protocol for Clinical Use in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Cognitive Impairment
Psychiatric Disorder
Keywords: major depressive disorder
tDCS
Lead sponsor: The National Brain Mapping Laboratory (NBML)
Sponsor class: OTHER
Collaborators: name: Leibniz Research Centre for Working Environment and Human Factors
name: Neuroelectrics Corporation
name: Zanjan University of Medical Sciences
First posted: 2023-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, parallel group trial
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Meet DSM-5 criteria for a moderate-to-severe major depression, primarily by a DSM-5-based structured interview by a licensed psychiatrist, confirmed by score on Hamilton Rating Scale for Depression (HAMD)
* 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 tricyclics (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)

Primary outcomes:
measure: depressive symptoms
timeFrame: up to 3 months after the intervention
measure: depressive symptoms
timeFrame: up to 3 months after the intervention
measure: depressive symptoms
timeFrame: up to 3 months after the intervention
Secondary outcomes:
measure: Working memory task
timeFrame: up to 1 month after the intervention
measure: Attention task
timeFrame: up to 1 month after the intervention
measure: Emotion Recognition Task
timeFrame: up to 1 month after the intervention
measure: electroencephalogram (EEG) functional connectivity
timeFrame: up to 1 week after the intervention
measure: electroencephalogram (EEG) power
timeFrame: up to 1 week after the intervention
Other outcomes:
Locations:
city: Zanjān
country: Iran, Islamic Republic of
facility: Zanjan University of Medical Sciences
state: Zanjan
Study officials:
References: