Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06165445
• Other study ID #: ifado-NE-ZUMS
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2023
• Source: The National Brain Mapping Laboratory (NBML)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Impairment
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Device:
• transcranial 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.
• multichannel 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Zanjan University of Medical Sciences	Zanjan	Zanjan

Sponsors (4)

Lead Sponsor	Collaborator
The National Brain Mapping Laboratory (NBML)	Leibniz-Institut für Arbeitsforschung, Neuroelectrics Corporation, Zanjan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	electroencephalogram (EEG) functional connectivity	Change in the EEG functional connectivity in the frontal areas	up to 1 week after the intervention
Secondary	electroencephalogram (EEG) power	Change in the EEG alpha/theta/gamma power	up to 1 week after the intervention