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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04708691
Other study ID # 201911100RIND
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date April 2023

Study information

Verified date May 2021
Source National Taiwan University Hospital
Contact Kuo Hsiao-I, PhD
Phone 02-33668137
Email hikuo@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Major depressive depression (MDD) affects a quarter of young adults and is associated with marked global burden in this population. Recently, growing literature has shown that cognitive dysfunction is common in young adults with depression. There is a vast amount of evidence indicating aerobic exercise has positive effects on cognitive function in healthy as well as in subjects with depression. The results might be dependent on neuroplastic changes induced by aerobic exercise. Nevertheless, the neurocognitive mechanisms of aerobic exercise in young adults with depression has not received systematic investigation. In addition, the association between the underlying brain physiology and cognitive performance has not been explored so far. In this project, the investigators aim to explore the relevance of a single session of aerobic exercise for human brain physiology and the impact of respective physiological effects on cognitive processes in young adults with depression.


Description:

The study are interested in the physiological foundation of the impact of aerobic exercise on cognitive performance in youth MDD subjects. Combined application of neurophysiological intervention and recording tools, including non-invasive brain stimulation, is suited to explore the impact of aerobic exercise on brain physiology and cognition in humans. We will apply transcranial magnetic stimulation (TMS) to obtain evoked potentials with electromyography (EMG) to explore cortical excitability. In the same participants, we will combine motor learning, working memory, and attention task to explore the association between the physiological effect of aerobic exercise and respective cognitive alterations. This project aims to explore the impact of aerobic exercise on cortical excitability and cognitive performance, and the association between these phenomena in youth MDD subjects. The study will improve our understanding of the role of aerobic exercise in cortical excitability, an important physiological basis for cognitive processes in humans, the underlying physiological mechanisms with regard to the aerobic exercise, and their functional relevance in youth MDD subjects.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 2023
Est. primary completion date April 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 35 Years
Eligibility Inclusion criteria 1. Diagnosis of major depressive disorder by a board-certified psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition 2. Total score of the 17-item Hamilton Rating Scale for Depression (HAM-D) less than 7 3. Aged between 18 to 35 years 4. Right handedness Exclusion criteria 1. A major depressive episode within the past three months 2. Pacemaker or deep brain stimulation 3. Metal implants in the head or neck area 4. Other major mental disorders including autism spectrum disorders, mental retardation, psychotic disorders, bipolar disorders, obsessive-compulsive disorder, and neurocognitive disorders 5. Alcohol or other illicit substance abuse 6. Neurological diseases involving the central nervous system 7. Major debilitating systemic diseases 8. Pregnancy 9. Breast feeding 10. Cigarette smoker 11. Color blindness 12. Take part in another study within the last 4 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic exercise
aerobic exercise

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cortical excitability TMS measurment 4 weeks
Secondary Cognitive task Serial reaction time task, 3-back letter task 4 weeks
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