Cognitive Impairment, Depressive Disorder, Psychiatric Disorder
Conditions
Keywords
major depressive disorder, tDCS
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.
Interventions
DEVICEtranscranial direct current stimulation (tDCS)
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.
DEVICEmultichannel transcranial direct current stimulation (tDCS)
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.
Sponsors
The National Brain Mapping Laboratory (NBML)
Leibniz Research Centre for Working Environment and Human Factors
Neuroelectrics Corporation
Zanjan University of Medical Sciences
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
to secure investigator blinding, interventions were applied by independent investigators who were not involved in outcome measure ratings
Intervention model description
randomized, double-blind, parallel group trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale scores | up to 3 months after the intervention | the score on the MADRS (Montgomery-Asberg Depression Rating Scale) |
| Hamilton Depression Rating Scale scores | up to 3 months after the intervention | 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 |
| Beck Depression Inventory scores | up to 3 months after the intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Working memory task | up to 1 month after the intervention | Performance in the Spatial Working Memory (SWM) task, which is a recommended test for depression by Cambridge Cognition (CANTAB) |
| Attention task | up to 1 month after the intervention | Performance in the Rapid Visual Information Processing (RVP) task, which is a recommended test for depression by Cambridge Cognition (CANTAB) |
| Emotion Recognition Task | up to 1 month after the intervention | Performance in the Emotion Recognition Task (ERT), which is a recommended test for depression by Cambridge Cognition (CANTAB) |
| electroencephalogram (EEG) functional connectivity | up to 1 week after the intervention | Change in the EEG functional connectivity in the frontal areas |
| electroencephalogram (EEG) power | up to 1 week after the intervention | Change in the EEG alpha/theta/gamma power |
Countries
Iran
Outcome results
None listed