Autonomic Nervous System and Meridian Energy in Patients With Schizophrenia

NCT06617104 | Recruiting

• 1 other identifier: 202407147RINC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the differences in autonomic nervous function and meridian energy between schizophrenia patients and healthy individuals. By understanding the meridian and organ conditions of individuals, the study aims to align with the traditional Chinese medicine (TCM) concept of "treating disease before it arises" and provide comprehensive care to patients, thereby improving the quality of care.

Conditions

Schizophrenia; Healthy Individuals

Outcome Measures

Primary Outcomes (2)

• meridian energy

  Measuring the body energy under static balance conditions using principles of electromagnetic induction technology.The measurement items include:lung meridian (LU), large intestine meridian (LI), stomach meridian (ST), spleen meridian (SP), heart meridian (HT), small intestine meridian (SI), bladder meridian (BL), kidney meridian (KI), pericardium meridian (PC), triple burner meridian (SJ), gallbladder meridian (GB), liver meridian (LR)

  This study is a cross-sectional study with a single follow-up. Participants who meet the inclusion criteria will be included in the study, with a recruitment period of one year.

• heart rate variability

  Assessing autonomic nervous system activity through the measurement of RR intervals. The measurement items include: the square root of the mean squared differences of successive NN intervals , NN50 count divided by the total number of all NN intervals, HRV triangular index, low frequency power, high frequency power, LF/HF Ratio, total power

  This study is a cross-sectional study with a single follow-up. Participants who meet the inclusion criteria will be included in the study, with a recruitment period of one year.

Study Arms (2)

schizophrenia

According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), individuals who meet the criteria for a diagnosis of schizophrenia.

Other: no intervention

healthy individuals

No history of chronic illness in the past and no acute symptoms within the past month.

Other: no intervention

Interventions

no intervention OTHER

no intervention

healthy individuals; schizophrenia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Disease group(schizophrenia):According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), individuals who meet the criteria for a diagnosis of schizophrenia. 2. Control group(healthy individuals):No history of chronic illness in the past and no acute symptoms within the past month.

You may qualify if:

• Disease group：
• Diagnosed with schizophrenia by a physician (ICD-10 code F20, such as F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, or F20.9), with stable condition, and has not had any changes in medication dosage or admission to a psychiatric acute care unit in the past 3 months.
• Aged between 18 and 65 years.
• Able to understand, speak, read, and write Mandarin or Taiwanese.
• Control group：
• No history of chronic illness and no acute symptoms within the past month.
• Aged between 18 and 65 years.
• Able to understand, speak, read, and write Mandarin or Taiwanese.

You may not qualify if:

• Disease group：
• Individuals with cardiovascular conditions, severe neurological disorders (e.g., organic brain disorders, early-stage dementia or diagnosed dementia), or substance abuse issues.
• Individuals who have used medications affecting the autonomic nervous system within the past month, such as mood stabilizers, antidepressants, angiotensin-converting enzyme inhibitors inhibitors, β-blockers, or antiarrhythmics.
• Individuals with metallic implants that could affect heart rate variability.
• Individuals with involuntary and uncontrollable body tremors.
• Women currently menstruating.
• Pregnant women.
• Control group：
• Individuals with cardiovascular conditions, severe neurological disorders (e.g., organic brain disorders, early-stage dementia or diagnosed dementia), or substance abuse issues.
• Individuals who have used medications affecting the autonomic nervous system within the past month, such as psychiatric medications, angiotensin-converting enzyme inhibitors inhibitors, β-blockers, or antiarrhythmics .
• Individuals with metallic implants that could affect heart rate variability.
• Individuals with involuntary and uncontrollable body tremors.
• Women currently menstruating.
• Pregnant women.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100229, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Yi-Min Pan

CONTACT

886-2-23123456; annie9674@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 27, 2024
• Study Start: September 5, 2024
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)