Transcranial Direct Current Stimulation for Depression

NCT ID: NCT06187454

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2026-12-31

Brief Summary

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Several studies have shown that tDCS is valuable and safe options to improve depressive symptoms in adult patients . However, regarding the tDCS to treat depression in elderly population, only few studies have been reported, and there is no consensus among them. To our knowledge, prefrontal cortex tDCS could be reasonably safe and efficient options for the treatment of several psychiatric illnesses in a population presenting resistance to and/or intolerance of pharmacotherapy . Moreover, the safety tolerability profile of tDCS is a strong argument in favour of exploring their use in the depressed population. Therefore, current study will investigate the efficacy and safety of prefrontal tDCS used as additive treatment in patients with LLD.

Detailed Description

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Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Active tDCS

Group Type EXPERIMENTAL

Active Transcranial direct current stimulation

Intervention Type DEVICE

Transcranial direct current stimulation (tDCS) is a method for noninvasive brain stimulation, where a weak electrical current is delivered through two scalp electrodes by a portable battery-powered stimulator.

Sham tDCS

Group Type SHAM_COMPARATOR

Sham Transcranial direct current stimulation

Intervention Type DEVICE

For sham tDCS, the electrode positions and stimulation parameters will be the same as that used for anodal stimulation except that the current will be delivered only for the initial 30 seconds.

Interventions

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Active Transcranial direct current stimulation

Transcranial direct current stimulation (tDCS) is a method for noninvasive brain stimulation, where a weak electrical current is delivered through two scalp electrodes by a portable battery-powered stimulator.

Intervention Type DEVICE

Sham Transcranial direct current stimulation

For sham tDCS, the electrode positions and stimulation parameters will be the same as that used for anodal stimulation except that the current will be delivered only for the initial 30 seconds.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Participants who meet the criteria of major depression defined by DSM-5 criteria
2. Participants will be non-responders and taking an antidepressant of adequate dose and for ≥4 weeks in the current episode which has not led to sufficient clinical improvement (defined as a minimum level of 2 on the ATHF); or can't tolerate the adverse effects of antidepressant in the current episode
3. Ambulatory participants with or without any aiding device

Exclusion Criteria

1. An urgent risk of suicide or severe depression
2. A history of ineffectiveness with tDCS
3. People who are clinically contraindicated to receive tDCS intervention or MRI assessment, such as having any brain lesion, intracranial implants (clips, cochlear implants), a tattoo or metal embedded in their scalp or brain
4. Any instable medical condition
5. A history of epilepsy,
6. A history of substance use (within one year)
7. People with dementia or psychotic disorder.
8. Any condition which would make the subject unsuitable for the study under the physician's assessment.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mu-N Liu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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TaipeiVGH

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Mu-N Liu, PhD

Role: CONTACT

0938595767

Facility Contacts

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Mu-N Liu, PhD

Role: primary

0938595767

Other Identifiers

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2020-07-020B

Identifier Type: -

Identifier Source: org_study_id

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