Transcranial Direct Current Stimulation (tDCS) and Immersive Virtual Reality Meditation (IVRM) for the Treatment of Anxiety Disorders

The University of Hong Kong (HKU)

Status: Invitation-only

Conditions: GAD; Anxiety

Treatments: Device: tDCS+IVRM (sham stimulation); Device: tDCS +IVRM (Active stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT07299916

tDCS_anxiety

Details and patient eligibility

About

The goal of this RCT is to evaluate the post-intervention (week 2) and 1-month post-intervention (week 6) of a 2-week intervention (12 sessions) of combined tDCS (a non-invasive brain stimulation method, with anodal stimulation over lDLPFC and cathodal stimulation over rDLPFC) and immersive virtual reality meditation (IVRM) on anxiety severity among individuals with anxiety disorders, as compared to sham group. We also assess the effects of the intervention on other secondary outcomes as compared to sham group, as well as the tolerability (how well people can handle it) and feasibility (how easy it is to carry out) of this combined intervention.

Exploratory analyses will examine physiological markers, such as heart rate variability (HRV), in relation to treatment response.

Participants will receive total 12 sessions of either active or sham tDCS on DLPFC paired with IVRM. The assessment will be blinded to assessors. No one (participants, researchers, assessors) will be revealed the group allocation. Sham tdcs applies the standard blinding protocol with 30 seconds of ramping up and ramping down periods.

Participants will:

Receive 12 total treatment sessions (twice a day for 2 weeks); each session is 20 minutes of tDCS (active or sham) plus IVRM. The IVRM uses HypnoVR® with 3D scenes (e.g., beach, forest) and 20-minute guided scripts meditation.Take a 20-minute break between the two daily sessions.

Complete assessments at three time points: baseline (before treatment, T0), right after the 2-week treatment (T1), and 1 month after treatment (T2). Assessments include anxiety tests (e.g., HAM-A, Beck Anxiety Inventory), adverse effect questionnaires (for tDCS and IVRM), and physiological checks (e.g., heart rate variability).

Enrollment: 52 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 16-70 years;
• Diagnosed with Generalized Anxiety Disorder (GAD) or Mixed Anxiety and Depressive Disorder (MADD) or Major Depressive Disorder with prominent anxiety symptoms, according to the Structured Clinical Interview for DSM-5, Clinical Version (SCID-DSM-5, CV)
• Scored ≥ 8 (i.e., at least mild to moderate anxiety on the 14-item Hamilton Anxiety Rating Scale (HAM-A)) at screening;
• 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, or focal brain lesions;
• First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease;
• Concomitant unstable medical condition or major neurological conditions;
• Comorbid disorders listed in the DSM-V, e.g., schizophrenia, mental retardation, etc.;
• Current or history of alcohol or drug abuse;
• Inability to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups

active tDCS stimulation + IVRM

Experimental group

Description:

Participants will receive 12 combined sessions (twice daily over 2 weeks), with each session being 20 minutes of active tDCS (delivering 2mA current, electrodes placed at left DLPFC (F3, anode) and right DLPFC (F4, cathode)) synchronized with immersive VR; a 20-minute interval between daily sessions

Treatment:

Device: tDCS +IVRM (Active stimulation)

Sham tDCS stimulation + IVRM

Sham Comparator group

Description:

Participants will receive 12 combined sessions (twice daily over 2 weeks), with each session being 20 minutes of sham tDCS synchronized with immersive VR; a 20-minute interval between daily sessions. In the sham condition, the current will be ramped up to 2mA within the first and last 30 seconds to mimic the sensation of stimulation, but then ramped down, with no current maintained at other times. Moreover, the stimulation mode of the tDCS device will be pre-set by a the principal investigator, who are not involved in the stimulation delivery or outcome measurements, both of which are conducted by a research assistant who are blinded to the stimulation mode.

Treatment:

Device: tDCS+IVRM (sham stimulation)