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Cognitive FunctioningNCT07747181

The Effect of Combined Brain Stimulation and Yoga for Improving Cognitive Function in Psychosis

A study testing Active tDCS and Yoga in people with Cognitive Functioning and Psychosis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study examines (1) the effects of active anodal (facilitatory) tDCS and yoga combined intervention on cognitive function, clinical symptoms, and quality of life domains (social function and physical wellbeing) in psychosis, and (2) the neurophysiological mechanisms underlying the effects induced by the combined… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cognitive Functioning, Psychosis
What is being tested?
Active tDCS and Yoga
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
1 siteHong Kong
Study dates
1 Jan 2026to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) aged 18 to 65 years
  • (2) diagnosis based on SCID for schizophrenia and related disorders, psychosis, and delusional disorder with the positive symptom measured by CGI ≤ 3
  • (3) ability to understand the nature of the study and to give informed consent (The MacArthur Competence Assessment Tool for Clinical Research score ≥ 35)
  • (4) Chinese-speaking
  • (5) fewer than 10 hours of yoga and other mind-body intervention (e.g., Tai Chi, Qigong, Mindfulness) in the previous 3 months.

Who cannot join

  • (1) Severe physical diseases, such as myocardial infarction, uncontrollable severe hypertension, fracture, severe spinal problems, or contraindication for exercise
  • (2) comorbid substance dependence and seizure disorders
  • (3) pregnancy or other contraindication to fNIRS
  • (4) known history of intellectual disability or special school attendance, brain trauma, or organic brain disease
  • (5) Individuals taking Benzodiazepine will still be recruited in the project, and will be excluded from the fNIRS measure.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Kong1 site, 1 recruiting
  • The Hong Kong Polytechnic University

    Hung Hom, Kowloon

    Prof. Jessie LIN, +85227666718, jx-jessie.lin@polyu.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Yoga and tDCS to Improve Cognitive Function in Individuals With Psychosis: A Pragmatic Controlled Trial

The study examines (1) the effects of active anodal (facilitatory) tDCS and yoga combined intervention on cognitive function, clinical symptoms, and quality of life domains (social function and physical wellbeing) in psychosis, and (2) the neurophysiological mechanisms underlying the effects induced by the combined intervention.

Being tested
Active tDCS, Sham tDCS, Yoga
Medical subject headings
Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active tDCSDevice

    Active tDCS will be applied using a wearable stimulator (LifTid) with a constant stimulation intensity of 1.2 mA for 20 minutes. The device has been designed for anodal stimulation targeting DLPFC using the F3 (anode) to F4 (cathode) montage.

  • Sham tDCSDevice

    Sham tDCS will be performed using the same device but without stimulation. During the yoga training, all participants will wear the device and a facilitator will turn on the stimulation for participants receiving a-tDCS-Y intervention, and pretend to turn on the stimulation for participants receiving s-tDCS-Y intervention after the first 10-minute section.

  • YogaBehavioural

    Yoga will be based on the basic theory and research of the foundation of Hatha yoga. Participants will cultivate the learning of yoga through various kinds of activity, such as breathing control, body postures, and relaxation. The yoga is designed to create an overall effect on the body and mind through strength training and stretching with a mindful sensation. Each 1-hour intervention session contains reviewing the last week self-practice, breathing practice and warm-up (10 minutes), posture sequences (40 minutes), relaxation (5 minutes), reflection and feedback (5 minutes). Video clips will be provided through social media apps (i.e., WhatsApp, WeChat) to enable home-based practice at least twice weekly. A logbook will be distributed to the participants for their record of self-practice and will be reviewed weekly by the intervention facilitator.

Study groups in NCT07747181
Study groupRoleWhat they receive
Active tDCS and yogaActive comparatorNot described
Receives: Device: Active tDCS; Behavioral: Yoga
Sham tDCS and yogaSham comparatorNot described
Receives: Device: Sham tDCS; Behavioral: Yoga
Waitlist control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Verbal Fluency Test

    A measure of executive function. Participants have to name as many animals as possible in 60 seconds. Higher scores indicate better executive functioning.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

Secondary outcomes (17)
  1. Logical Memory test

    The Logical Memory test is a standardized test used to evaluate narrative verbal memory, immediate free recall, and delayed free recall. The examiner reads one short, structured stories aloud to the participant. The test consists of two main parts: Logical Memory I (Immediate Recall), where the participant is asked to retell the story from memory immediately after hearing it, and Logical Memory II (Delayed Recall), where the participant is asked to retell the story again after a 30-minute delay. Scoring is based on the total number of predefined story elements or ideas correctly recalled. For each story, the raw score ranges from 0 to 23 story units. Higher scores indicate better verbal memory and auditory narrative recall capabilities.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  2. Digit Span Test

    The Digit Span Test is a standardized cognitive subtest used to evaluate short-term verbal memory, attention, and working memory. The examiner reads a sequence of random numbers aloud at a rate of one digit per second, and the participant is asked to repeat them. The test consists of two primary components: Digit Span Forward (where digits are repeated in the exact order heard to assess attention and short-term memory) and Digit Span Backward (where digits are repeated in the reverse order to assess working memory and mental manipulation). Scoring is based on the total number of trials correctly recalled. Higher scores indicate better auditory attention, short-term memory capacity, and working memory functioning.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  3. Positive and Negative Syndrome Scale (PANSS)

    The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale used to measure the symptom severity of patients with schizophrenia. It consists of three subscales: the Positive Scale (7 items), the Negative Scale (7 items), and the General Psychopathology Scale (16 items). Each item is rated on a 7-point symptom-severity scale from 1 (absent) to 7 (extreme). The total score ranges from a minimum of 30 to a maximum of 210. Higher scores indicate greater severity of psychiatric symptoms.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  4. Calgary Depression Scale

    The Calgary Depression Scale is a 9-item structured interview scale specifically designed to assess the severity of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale from 0 (absent) to 3 (severe). The total score ranges from a minimum of 0 to a maximum of 27. Higher scores indicate more severe depressive symptoms.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  5. Social and Occupational Functioning Assessment Scale (SOFAS)

    The Social and Occupational Functioning Assessment Scale (SOFAS) is a clinician-rated numeric scale used to assess an individual's level of social and occupational functioning, distinct from the severity of their psychological or psychiatric symptoms. The scale ratings range from 1 to 100, divided into 10-point intervals. A score of 100 represents superior functioning in a wide range of activities, while a score of 1 indicates a persistent inability to maintain minimal personal hygiene or gross impairment in social and occupational functioning. Higher scores indicate a higher level of social and occupational functioning and greater independence.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  6. Role Functioning Scale (RFS)

    The Role Functioning Scale (RFS) is a 4-item instrument designed to assess the level of functioning of individuals with severe mental illness in four areas: Working Productivity, Immediate Past Social Network, Extended Social Network, and Independent Living / Self-Care. Each of the 4 domains is rated on a 7-point behavioral index scale ranging from 1 (severely impaired) to 7 (optimal functioning). The total score ranges from a minimum of 4 to a maximum of 28. Higher scores indicate a higher level of role functioning and greater independence.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  7. The Short Form Health Survey (SF-36)

    The 36-Item Short Form Health Survey (SF-36) is a patient-reported questionnaire used to assess health-related quality of life. It measures eight health domains: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well-Being, Social Functioning, Pain, and General Health. Responses are multi-choice, and individual domain scores are transformed onto a scale from 0 to 100. For each domain and summary score, the scale range is 0 to 100, where higher scores indicate better health status and higher quality of life.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  8. BMI

    Body Mass Index (BMI) is a standardized anthropometric measure used to estimate body fat and classify weight status. It is calculated by dividing an individual's body weight in kilograms by the square of their height in meters (kg/m²). Higher BMI values indicate greater body mass relative to height, which can correspond to higher body fat levels.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  9. Sit-and-Reach Test

    A common measure of flexibility, specifically assessing the lower back and hamstring muscles. The subject is seated against the wall, arms outstretched towards the box. A sliding ruler is used to measure the position of the fingertips. Higher scores (greater distance reached) indicate greater hamstring and lower back flexibility.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  10. Standing Balance Test

    Give the subject a minute to practice their balancing before starting the test. Then ask the person to stand on one foot for as long as possible. The total length of time a person can stay in the balance position will be recorded. The timing stops when the elevated foot touches the ground or the person hops or otherwise loses their balance position. The test will be conducted with the person having their arms on their waist. Repeat the test on the other leg. Higher scores (longer durations) indicate better static balance and postural control.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  11. Digit Symbol Coding Test

    The Digit Symbol Coding Test is a standardized paper-and-pencil neurocognitive task used to assess processing speed, attention, psychomotor performance, and visual-motor coordination. Participants are presented with a key pairing single digits (1 through 9) with unique geometric symbols. Below the key, rows of digits are displayed with empty spaces beneath them. Participants are instructed to write the correct corresponding symbol for each digit as quickly and accurately as possible within 120 seconds. The outcome score is calculated as the total number of correct digit-symbol pairs completed within the time frame. Higher scores indicate superior processing speed and enhanced cognitive efficiency.

    Measured: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  12. Letter Cancellation Test

    The Letter Cancellation Test is a standardized paper-and-pencil psychomotor task used to assess visual attention, sustained attention, psychomotor speed, and visual neglect. Participants are presented with a sheet of paper containing rows of random letters and are instructed to cross out (cancel) a specific target letters as quickly and accurately as possible. The outcome score is reported as the total number of correct targets identified (hits). Higher scores indicate superior visual attention and faster processing speed.

    Measured: After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  13. Trail Making Test (TMT)

    The Trail Making Test (TMT) is a standard neurocognitive task used to assess visual search, scanning, processing speed, and executive function. It consists of two distinct parts: Part A and Part B. In Part A (TMT-A), participants are instructed to connect a series of encircled numbers in chronological order (1-2-3, etc.) as quickly and accurately as possible. In Part B (TMT-B), participants must connect a alternating series of encircled numbers and letters in sequential order (1-A-2-B-3-C, etc.). The outcome score for each part is recorded as the total time in seconds required to complete the trail. Lower scores (shorter durations to complete the task) indicate superior processing speed, enhanced cognitive flexibility, and better executive functioning.

    Measured: After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

  14. Changes of HbO and HbR in prefrontal regions during resting and cognitive task measured by fNIRS

    Functional Near-Infrared Spectroscopy (fNIRS) is a non-invasive optical imaging technique used to monitor hemodynamic responses in the cerebral cortex. This outcome measure evaluates the relative concentration changes of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) within defined regions of interest in the prefrontal cortex (PFC). Measurements are continuously recorded during two distinct states: a resting-state baseline condition and a target cognitive task condition. Increased HbO concentration accompanied by a concurrent decrease in HbR concentration relative to baseline indicates localized cortical activation in the prefrontal region during the cognitive task.

    Measured: Baseline (T0), and after the 6-week interventions/waiting (T1)

  15. Correlation of changes in HbO and HbR among prefrontal regions (connectivity)

    Functional connectivity within the prefrontal cortex (PFC) is evaluated by measuring the temporal correlation of hemodynamic signal fluctuations. Continuous fNIRS data for both oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) are recorded during resting-state and the cognitive task. After preprocessing to remove systemic noise and motion artifacts, the functional connectivity is quantified by calculating the Pearson correlation coefficient (r) and its Fisher z-transformed equivalent between the time courses of different prefrontal regions. The resulting correlation values range from -1.0 to +1.0 . Higher positive values indicate stronger functional connectivity and greater synchronized neural activity between those specific prefrontal cortical regions.

    Measured: Baseline (T0), and after the 6-week interventions/waiting (T1)

  16. Attendance of the interventions

    Number of class attended during the 6-week intervention.

    Measured: After the 6-week interventions/waiting (T1)

  17. Home-based practice frequency and duration checklist

    Participants report the frequency and duration of doing the home-based practice.

    Measured: After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2026
  2. Study start1 Jan 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07747181
Sponsor's protocol ID
25124024
Status last verified
Aug 2026
First submitted
30 Jul 2026
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active tDCS and Yoga in people with Cognitive Functioning and Psychosis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Verbal Fluency Test (time frame: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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