Transcranial Direct Current Stimulation (tDCS) in Young Individuals with Major Depressive Disorder: a Literature Review and Feasibility Study
- Conditions
- Major Depressive Disorder
- Interventions
- Device: Sooma tDCS portable device - sham stimulationDevice: Sooma tDCS portable device - active stimulation
- Registration Number
- NCT06518642
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham stimulation Sooma tDCS portable device - 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 active stimulation Sooma tDCS portable device - 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.
- Primary Outcome Measures
Name Time Method Hamilton Depression Rating Scale (HDRS) - 17 items T0 (baseline); T1 (immedately after intervention) Measuring depressive symptoms, score ranges from 0 (minimum) to 53 (maximum); higher score indicates more severe depressive symptoms.
- Secondary Outcome Measures
Name Time Method Visual Analog Scale (VAS) T0 (baseline); T1 (immedately after intervention) Two VASs were used to measure motivation and willingness during intervention. Each VAS contains a scale of 0 (minimum) to 10 (maximum) with higher scores indicating more
Chinese version of the Dimensional Anhedonia Rating Scale (C-DARS) T0 (baseline); T1 (immedately after intervention) 17-item self-rated questionnaire measuring anhedonia symptoms. Each item ranges from 0 to 4, hence total score ranges from 0 (minimum) to 68 (maximum) with higher scores indicating lower levels of anhedonia symptoms
Adherence rate to the participation of the tDCS study from T0 (baseline) to T1 (immedately after intervention) Adherence rate of full participation in each tDCS session; and the reason of skipping the tDCS session if any
Social and Occupational Functioning Assessment scale (SOFAS) T0 (baseline); T1 (immedately after intervention) Measures social and occupational functioning across work functioning, independent functioning, immediate and extended social network functioning; score ranges from 0 (minimum) to 100 (maximum), higher score indicates higher social and occupational functioning ability.
Beck Scale of Suicidal Ideation. T0 (baseline); T1 (immedately after intervention) Measures self-reported suicidal ideation; score ranges from 0 (minimum) to 38 (maximum), with higher scores indicating a greater risk of suicide.
Global Functioning: Social Scale and Role Scale T0 (baseline); T1 (immedately after intervention) Measures social and role functioning; score ranges from 1 (minimum) to 10 (maximum); higher score indicates better social/role functioning
Short Form Health Survey (SF-12) T0 (baseline); T1 (immedately after intervention) Short-form measure of health status with 12 questions.
Chinese version of the Snaith-Hamilton Pleasure Scale (C-SHAPS) T0 (baseline); T1 (immedately after intervention) Gold standard, self-rated scale measuring anhedonia symptoms. Each item ranges from 0 to 3, hence total score ranges from 0 (minimum) to 42 (maximum) with higher scores indicating more anhedonic symptoms
Role Functioning Scale (RFS) T0 (baseline); T1 (immedately after intervention) Measures role functioning in four areas: work productivity, independent living, immediate and extended social network relationships; score ranges from 0 (minimum) to 7 (maximum) on each aspect, higher score indicates better role functioning
Clinical Global Impression Scale T1 (immedately after intervention) Measures the severity of illness and global improvement following an intervention; scores ranges from 1 (normal/very much improved) to 7 (most severely ill/very much worse), with higher scores indicating worse outcome.
Trial Locations
- Locations (1)
University of Hong Kong
🇭🇰Hong Kong, Hong Kong