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

NCT ID: NCT07299916

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2027-03-30

Brief Summary

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).

Conditions

Anxiety; GAD

Keywords

immersive virtual reality meditation; Transcranial Direct Current Stimulation (tDCS); Augmentative treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active tDCS stimulation + IVRM

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

Group Type: EXPERIMENTAL

tDCS +IVRM (Active stimulation)

Intervention Type: DEVICE

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 .The IVRM will employ guided meditation VR (Brainrise , France) ,as a technology based mindfulness based treatment, with standardised meditation scripts, using Oculus Rift VR headset. The current will be applied with the anode positioned left DLPFC, corresponding to area F3 in the international 10-20 system. The cathode will be applied at the right dPLFC, F4

Sham tDCS stimulation + IVRM

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.

Group Type: SHAM_COMPARATOR

tDCS+IVRM (sham stimulation)

Intervention Type: DEVICE

Participants will receive 12 sessions of sham tDCS stimulation paired with concurrent IVRM. Stimulation is delivered using a tDCS device (Soterix Medical), anodal stimulation at lDLPFC and cathodal stimulation at RFLPFC. The IVRM will employ guided meditation VR (Brainrise , France) ,as a technology based mindfulness based treatment, with standardised meditation scripts, using Oculus Rift VR headset. 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.

Interventions

tDCS +IVRM (Active stimulation)

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 .The IVRM will employ guided meditation VR (Brainrise , France) ,as a technology based mindfulness based treatment, with standardised meditation scripts, using Oculus Rift VR headset. The current will be applied with the anode positioned left DLPFC, corresponding to area F3 in the international 10-20 system. The cathode will be applied at the right dPLFC, F4

Intervention Type: DEVICE

tDCS+IVRM (sham stimulation)

Participants will receive 12 sessions of sham tDCS stimulation paired with concurrent IVRM. Stimulation is delivered using a tDCS device (Soterix Medical), anodal stimulation at lDLPFC and cathodal stimulation at RFLPFC. The IVRM will employ guided meditation VR (Brainrise , France) ,as a technology based mindfulness based treatment, with standardised meditation scripts, using Oculus Rift VR headset. 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Lo Ka Ying

the hku mood team

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Hong Kong, Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

tDCS_anxiety

Identifier Type: -

Identifier Source: org_study_id