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Transcranial Direct Current Stimulation (tDCS) in Young Individuals with Major Depressive Disorder: a Literature Review and Feasibility Study

NCT ID: NCT06518642

Last Updated: 2024-11-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2024-10-31

Brief Summary

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Objectives: (1) To assess the therapeutic effects of tDCS on improving depressive symptoms in young individuals with Major Depressive Disorder (MDD), relative to sham stimulation ; and (2) to evaluate the tolerability, and feasibility of tDCS in young individuals with Major Depressive Disorder, to explore the feasibility for a scale-up study.

Hypothesis: 1) we hypothesize the tDCS stimulation of the dorsolateral prefrontal cortex (dLPFC) will reduce symptoms of depression more than sham stimulation, demonstrated by significant difference in change of Hamilton Depression Rating Scale (HDRS) and 2) tDCS active stimulation of the dLPFC will be tolerable and feasible among patients with MDD, as demonstrated by minimal adverse effects measured in the Adverse Events Questionnaire, adherence (with reasons of drop out), their motivation and enjoyment to participate in the study .

Detailed Description

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The incidence of probable depression during the fifth peak of COVID-19 was 24.6%, within the HK population, with the youths having experienced a disproportionately higher rate. A recent epidemiology survey conducted in HK revealed the 12-month prevalence of suicidal ideation among young individuals above secondary school age to be an alarming 8.4%. While guidelines and RCTs support the use of medication and psychotherapy as a standalone or combination treatments for major depressive disorder (MDD) in youths, a large proportion do not respond to either medication or psychotherapy. There is therefore an unmet need for new, effective treatment options for depression that can be tolerated by young individuals. Transcranial direct current simulation (tDCS) has its acute-effect is physiological change that reduces the threshold of membrane polarisation and increased the synaptic excitability. A handful of studies suggested that anodal stimulation of the dorsal lateral prefrontal cortex (DLPFC) is effective in reducing depressive symptoms in adults, however, whether similar effects applies to youth remains unknown. tDCS is portable, relatively inexpensive, and easy to use, proving to be very safe and tolerable for young individuals with minimal and temporary side effects.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
At the beginning of the stimulations sessions, participants receiving both the active and sham stimulation would experience a ramp-up in current from 0 to 2 mA, then the current would ramp down to 0 mA for participants receiving sham stimulation.

Participants were told that they may experience sensations such as tingling, headache, or mild burning during the first 30 - 60 seconds of the stimulation session but that they may subside afterwards as they got used to it. In other words, participants would not be able to tell if diminishing of side effects were due to habituation (active tDCS) or ramping down of current (sham tDCS).

Moreover, the stimulation mode of the tDCS device was pre-set by a the principal investigator, who was not involved in the stimulation delivery or outcome measurements, both of which were conducted by a research assistant who was blinded to the stimulation mode.

Study Groups

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active stimulation

A current strength of two mA will be consistently applied for 30 minutes, with 30 seconds of ramping up and ramping down periods.

Group Type EXPERIMENTAL

Sooma tDCS portable device - active stimulation

Intervention Type DEVICE

Treatment followed common tDCS protocol upon considering safety and tolerability, comprising five consecutive sessions in five days of 30-minute 2 mA tDCS. We utilized the Soterix Medical tDCS device (Soterix Medical, New York, NY, USA, Model 1x1 tDCS-CT) in the research lab and the Sooma Oy device (Sooma Depression Therapy Comfort, Helsinki, Finland) for patient self-administration.Sooma provided two of their portable tDCS devices for a brief period, including one customized sham device.Due to the limited availability of the Sooma devices, participants were randomly allocated to either the Sooma or. Due to the limited availability of the Sooma devices, participants were randomly allocated to either the Sooma or the Soterix device based on availability during their initial session. A current of 2 mA was applied with the anode positioned left DLPFC, corresponding to area F3 in the international 10-20 system. The cathode (reference electrode) was applied at the right dPLFC, F4.

sham stimulation

Current application will remain identical to the active stimulation, except that stimulation will be tampered off after 30 seconds. This duration (30 secs) was selected based on previous studies indicating that mild discomfort during active current application, such as tingling, would commonly be experienced up to 30 seconds only before subsiding

Group Type SHAM_COMPARATOR

Sooma tDCS portable device - sham stimulation

Intervention Type DEVICE

Sooma provided two of their portable tDCS devices for a brief period, including one customized sham device for effective blinding, distinguishable only by serial number and managed by an external data manager following the randomization sequence.To ensure blinding to the participant and their caregiver, at the beginning of the stimulation sessions, participants receiving both the active and sham stimulation would experience a ramp-up in current from 0 to 2 mA, and then the current would ramp down to 0 mA for participants receiving sham stimulation. Participants were told that they may experience sensations such as tingling, headache, or mild burning during the first 30-60 seconds of the stimulation session but that they may subside afterwards as they got used to it. In other words, participants would not be able to tell if diminishing of side effects were due to habituation (active tDCS) or ramping down of current (sham tDCS).

Interventions

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Sooma tDCS portable device - active stimulation

Treatment followed common tDCS protocol upon considering safety and tolerability, comprising five consecutive sessions in five days of 30-minute 2 mA tDCS. We utilized the Soterix Medical tDCS device (Soterix Medical, New York, NY, USA, Model 1x1 tDCS-CT) in the research lab and the Sooma Oy device (Sooma Depression Therapy Comfort, Helsinki, Finland) for patient self-administration.Sooma provided two of their portable tDCS devices for a brief period, including one customized sham device.Due to the limited availability of the Sooma devices, participants were randomly allocated to either the Sooma or. Due to the limited availability of the Sooma devices, participants were randomly allocated to either the Sooma or the Soterix device based on availability during their initial session. A current of 2 mA was applied with the anode positioned left DLPFC, corresponding to area F3 in the international 10-20 system. The cathode (reference electrode) was applied at the right dPLFC, F4.

Intervention Type DEVICE

Sooma tDCS portable device - sham stimulation

Sooma provided two of their portable tDCS devices for a brief period, including one customized sham device for effective blinding, distinguishable only by serial number and managed by an external data manager following the randomization sequence.To ensure blinding to the participant and their caregiver, at the beginning of the stimulation sessions, participants receiving both the active and sham stimulation would experience a ramp-up in current from 0 to 2 mA, and then the current would ramp down to 0 mA for participants receiving sham stimulation. Participants were told that they may experience sensations such as tingling, headache, or mild burning during the first 30-60 seconds of the stimulation session but that they may subside afterwards as they got used to it. In other words, participants would not be able to tell if diminishing of side effects were due to habituation (active tDCS) or ramping down of current (sham tDCS).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with major depressive disorder (MDD) according to the Structured Clinical Interview for DSM-5, Clinical Version (SCID-DSM-5, CV)
* Scored ≥ 14 (i.e., at least mild to moderate depression on the 17-item Hamilton Depression Rating Scale (HDRS) at screening and at baseline;
* Right handedness;
* Stable dosage of antidepressants or other treatments for depression in recent 4 weeks; and
* Can read and write Chinese.

Exclusion Criteria

* History of significant head trauma, neurological disorders (e.g., epilepsy), seizures;
* First degree relative with epilepsy;
* Concomitant unstable medical conditions; major neurological conditions;
* Comorbid disorders listed in the DSM-V, e.g., schizophrenia, substance use disorder, mental retardation, etc.;
* Pregnancy, lactating women, or women planning pregnancy;
* Device or metal clips on or inside the skull, cardiac pacemaker;
* Inability to provide informed consent.
Minimum Eligible Age

16 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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tDCS_depression

Identifier Type: -

Identifier Source: org_study_id