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Clinical Trials in China / NCT07389213
Recruiting Not applicable

Efficacy and Safety of rTMS Combined With HA in the Treatment of Cognitive Decline in Aged Related Hearing Loss

NCT07389213 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Not applicable
Started
2025-05-01
Last updated
2026-02-05

Condition(s) studied

Senile Deadness

Investigational drug(s) / intervention(s)

repetitive Transcranial Magnetic Stimulation (rTMS)

repetitive Transcranial Magnetic Stimulation (rTMS): High-frequency repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that modulates neural activity by delivering magnetic pulses to specific regions of the cerebral cortex. In this study, 50 Hz high-frequency stimulation will be used to enhance neuronal excitability, with stimulation intensity set at 80%-100% of the individual's motor threshold (MT) to accommodate the tolerance of elderly patients. Using each participant's MRI for neuronavigation, the stimulation coil will be precisely positioned over the left dorsolateral prefrontal cortex (DLPFC). Stimulation will be administered while the patient is awake, with each session lasting 9 minutes, delivered once daily. A single treatment course consists of 14 consecutive days, and a total of two courses will be conducted. Patient status will be closely monitored throughout the intervention to ensure safety and accuracy.

Study summary

This study is a real-world interventional trial enrolling 189 participants: older adults with age-related hearing loss not using hearing aids (ARHL-nonHA), those using hearing aids (ARHL-HA), and those with normal hearing (HC). All groups will undergo hearing, cognitive (MMSE, MoCA, SCWT, DST, TMT), depression (GDS-15, HAMD-24), sleep (PSQI), and brain imaging (EEG, sMRI, rs-fMRI, task-fMRI) assessments. The ARHL-nonHA and ARHL-HA groups will receive two 14-day courses of high-frequency rTMS (one session daily). One month after treatment, reassessments will be conducted in these two groups. Data will then be analyzed to evaluate the cognitive benefits of rTMS combined with hearing aids and to explore the underlying brain mechanisms.

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age ≥50 years and ≤85 years, regardless of gender. 2. Diagnosed with age-related hearing loss (ARHL), characterized by symmetrical, slowly progressing hearing loss primarily affecting high frequencies, along with decreased speech recognition ability due to aging. This is in accordance with the "Expert Consensus on Diagnosis and Intervention of Age-Related Hearing Loss" 2019 edition.(Only ARHL-nonHA group and ARHL-HA group) 3. The better ear has moderate, moderately severe, or severe hearing loss (based on the 2021 WHO hearing classification standards, i.e., PTA between 35～79dB). 4. Wearing hearing aids for more than half a year, with daily wearing time exceeding 7.2 hours; (Only ARHL-HA group) 5. Chinese nationals who can complete all assessments in Chinese. 6. Right-handed. 7. Educational level of at least 6 years. 8. Informed consent obtained, agreeing to participate in the trial with no plans to relocate within one year. Exclusion Criteria: 1. Exclusion of hearing loss due to noise, genetics, ototoxic drugs, or other non-age-related causes; 2. History of central nervous system disorders such as cerebral infarction, stroke, epilepsy, or traumatic brain injury; 3. Diagnosis of dementia or other neurodegenerative diseases that affect compliance with the study; 4. Presence of major neurological disorders, severe systemic diseases, family history of hereditary conditions, or major psychiatric disorders; 5. Contraindications to MRI; 6. Contraindications to rTMS.

Primary outcome measure(s)

  • Montreal Cognitive Assessment(MoCA ) improvement value — Baseline、Post-intervention 2 weeks and Post-intervention 1 month
    The Montreal Cognitive Assessment (MoCA) ranges from 0 to 30, with higher scores indicating better cognitive function; a score of 26 or above is generally considered normal. The overall cognitive function in all groups with hearing loss was assessed using the MoCA scale before and after intervention, and the difference was calculated.

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen Memorial Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07389213 on ClinicalTrials.gov ↗ ← All trials in China