Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder
- Conditions
- Psychiatric DisorderDepressive DisorderCognitive Impairment
- Interventions
- Device: transcranial direct current stimulation (tDCS)Device: multichannel transcranial direct current stimulation (tDCS)
- Registration Number
- NCT06165445
- Lead Sponsor
- The National Brain Mapping Laboratory (NBML)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description conventional tDCS group transcranial direct current stimulation (tDCS) 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 multi-channel tDCS group multichannel transcranial direct current stimulation (tDCS) 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 sham tDCS group transcranial direct current stimulation (tDCS) The conventional tDCS group will receive 30 session of 20-minute placebo stimulation using standard electrodes (7 x 5 cm) over the target region
- Primary Outcome Measures
Name Time Method depressive symptoms 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 Outcome Measures
Name Time Method 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)
electroencephalogram (EEG) functional connectivity up to 1 week after the intervention Change in the EEG functional connectivity in the frontal areas
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) power up to 1 week after the intervention Change in the EEG alpha/theta/gamma power
Trial Locations
- Locations (1)
Zanjan University of Medical Sciences
🇮🇷Zanjān, Zanjan, Iran, Islamic Republic of