Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder

The National Brain Mapping Laboratory (NBML)

Status: Completed

Conditions: Psychiatric Disorder; Cognitive Impairment; Depressive Disorder

Treatments: Device: transcranial direct current stimulation (tDCS); Device: multichannel transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06165445

ifado-NE-ZUMS

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

conventional tDCS group

Active Comparator group

Description:

The conventional tDCS group will receive 30 sessions of 20-minute stimulation at 2 mA intensities using standard electrodes (7 x 5 cm) over the target region

Treatment:

Device: transcranial direct current stimulation (tDCS)

multi-channel tDCS group

Active Comparator group

Description:

The multi-channel tDCS group will receive 30 sessions of 20-minute stimulation at 2 mA intensities using 7 electrodes (11 mm) over the target region

Treatment:

Device: multichannel transcranial direct current stimulation (tDCS)

sham tDCS group

Placebo Comparator group

Description:

The conventional tDCS group will receive 30 session of 20-minute placebo stimulation using standard electrodes (7 x 5 cm) over the target region

Treatment:

Device: transcranial direct current stimulation (tDCS)