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

NCT06518642 | Completed DMC

• 1 other identifier: tDCS_depression
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 .

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder (MDD); Youth; Transcranial Direct Current Stimulation (tDCS); Augmentative treatment; Young adults; Adolescent

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS) - 17 items

  Measuring depressive symptoms, score ranges from 0 (minimum) to 53 (maximum); higher score indicates more severe depressive symptoms.

  T0 (baseline); T1 (immedately after intervention)

Secondary Outcomes (10)

• Social and Occupational Functioning Assessment scale (SOFAS)

  T0 (baseline); T1 (immedately after intervention)

• Role Functioning Scale (RFS)

  T0 (baseline); T1 (immedately after intervention)

• Global Functioning: Social Scale and Role Scale

  T0 (baseline); T1 (immedately after intervention)

• Short Form Health Survey (SF-12)

  T0 (baseline); T1 (immedately after intervention)

• Clinical Global Impression Scale

  T1 (immedately after intervention)

Study Arms (2)

active stimulation

EXPERIMENTAL

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

Device: Sooma tDCS portable device - active stimulation

sham stimulation

SHAM COMPARATOR

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

Device: Sooma tDCS portable device - sham stimulation

Interventions

Sooma tDCS portable device - active stimulation 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.

active stimulation

Sooma tDCS portable device - sham stimulation 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).

sham stimulation

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: July 31, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-07

Locations

HK (1)