Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 5100000, China
Location status: Recruiting
Recruiting
NCT Number: NCT07389213
Efficacy and Safety of rTMS Combined With HA in the Treatment of Cognitive Decline in Aged Related Hearing Loss
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.
Recruiting
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Conditions
Age range
50 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
This study plans to conduct an interventional real-world study, enrolling 189 participants according to inclusion and exclusion criteria, including elderly patients with age-related hearing loss who do not wear hearing aids (ARHL-nonHA group), elderly patients with age-related hearing loss who wear hearing aids (ARHL-HA group), and elderly individuals with normal hearing (HC group). Audiological assessments (pure-tone average PTA, speech recognition threshold SRT), cognitive function assessments (Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Stroop Color-Word Test(SCWT), Digit Span Test (DST), Trail Making Test A (TMT-A), Trail Making Test B(TMT-B)), depression and sleep assessments (Geriatric Depression Scale (GDS-15), Hamilton Depression Rating Scale (HAMD-24), Pittsburgh Sleep Quality Index (PSQI)), and imaging assessments (resting-state (EEG), structural (sMRI), resting-state functional (rs-fMRI), task-based functional (task-fMRI)) will be performed on these three groups of participants. The ARHL-nonHA group and the ARHL-HA group will receive high-frequency repetitive Transcranial Magnetic Stimulation(rTMS) for two treatment courses, with each course lasting 14 days and one session per day. One month later, audiometric, cognitive, and imaging assessments will be repeated for the ARHL-nonHA and ARHL-HA groups. After the study, data will be collected and analyzed to evaluate the improvement effects of rTMS combined with HA on cognitive function in elderly patients with hearing loss, as well as its underlying brain functional mechanisms.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age ≥50 years and ≤85 years, regardless of gender.
- 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)
- 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).
- Wearing hearing aids for more than half a year, with daily wearing time exceeding 7.2 hours; (Only ARHL-HA group)
- Chinese nationals who can complete all assessments in Chinese.
- Right-handed.
- Educational level of at least 6 years.
- Informed consent obtained, agreeing to participate in the trial with no plans to relocate within one year.
Exclusion criteria
- Exclusion of hearing loss due to noise, genetics, ototoxic drugs, or other non-age-related causes;
- History of central nervous system disorders such as cerebral infarction, stroke, epilepsy, or traumatic brain injury;
- Diagnosis of dementia or other neurodegenerative diseases that affect compliance with the study;
- Presence of major neurological disorders, severe systemic diseases, family history of hereditary conditions, or major psychiatric disorders;
- Contraindications to MRI;
- Contraindications to rTMS.
Treatment and study plan
Repetitive transcranial magnetic stimulation (rTMS)
DeviceHigh-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.
Primary outcomes
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Montreal Cognitive Assessment(MoCA ) improvement value
Time frame: 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.
Secondary outcomes
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Mini-Mental State Examination(MMSE) improvement value
Time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month
The Mini-Mental State Examination (MMSE) is scored on a scale from 0 to 30, with higher scores indicating better cognitive function.
Overall cognitive function was assessed in all groups using the MMSE before and after the intervention, and the change scores were calculated.
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Pure-Tone Average(PTA) improvement value
Time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month
The Pure-Tone Average (PTA) is calculated as the mean hearing threshold (in decibels hearing level, dB HL) at 500 Hz, 1 kHz, 2 kHz, and 4 kHz before and after intervention in the ARHL-HA group and the ARHL-nonHA group was assessed using pure-tone audiometry and sound field audiometry, and the difference was calculated.
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Speech Reception Threshold(SRT) improvement value
Time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month
The Speech Reception Threshold (SRT) is the lowest intensity levelat which a person correctly identifies 50% of spondaic (two-syllable) words were correctly identified before and after intervention in the ARHL-HA group and the ARHL-nonHA group was assessed using speech audiometry and sound field speech audiometry, and the difference was calculated.
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Trail Making Test Part A (TMT-A) improvement value
Time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month
The Trail Making Test Part A (TMT-A) is scored based on the time (in seconds) required to complete the task, with lower scores indicating better attention and information processing speed.
The attention and information processing speed in the ARHL-HA group and the ARHL-nonHA group were assessed using the TMT-A before and after intervention, and the difference was calculated.
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Trail Making Test Part B (TMT-B) improvement value
Time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month
The Trail Making Test Part B (TMT-B) is scored based on the time (in seconds) required to complete the task, with lower scores indicating better set-shifting ability and executive function.
The set-shifting component of executive function in the ARHL-HA group and the ARHL-nonHA group was assessed using the TMT-B before and after intervention, and the difference was calculated.
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Digit Span Test (DST)improvement value
Time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month
The Digit Span Test (DST) is scored as the total number of correctly recalled digit sequences, with a typical total raw score ranging from 0 to 8. Higher scores indicate better attention, short-term memory, and working memory.
Attention, short-term memory, and working memory in the ARHL-HA group and the ARHL-nonHA group were assessed using the DST before and after intervention, and the difference was calculated.
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Stroop Color and Word Test (SCWT) improvement value
Time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month
The Stroop Color and Word Test (SCWT) is typically scored based on the time (in seconds) required to complete specific conditions .Lower completion times or lower interference scores indicate better inhibitory control and faster information processing speed, meaning lower values represent a better outcome.
The inhibitory control of dominant responses and information processing speed, as components of executive function, in the ARHL-HA group and the ARHL-nonHA group were assessed using the SCWT before and after intervention, and the difference was calculated.
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15-item Geriatric Depression Scale (GDS-15) improvement value
Time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month
The 15-item Geriatric Depression Scale (GDS-15) is scored by summing the number of depressive symptom responses, with total scores ranging from 0 (no depressive symptoms) to 15 (most severe depressive symptoms). Higher scores indicate greater severity of depressive symptoms.
Depressive symptom scores in the ARHL-HA group and the ARHL-nonHA group were assessed using the GDS-15 before and after intervention, and the difference was calculated.
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24-item Hamilton Depression Rating Scale (HAMD-24)improvement value
Time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month
The 24-item Hamilton Depression Rating Scale (HAMD-24) is a clinician-administered measure of depressive symptom severity, with total scores ranging from 0 to 76. Higher scores indicate more severe depression.
Depressive symptom scores in the ARHL-HA group and the ARHL-nonHA group were assessed using the HAMD-24 before and after intervention, and the difference was calculated.
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Pittsburgh Sleep Quality Index (PSQI) improvement value
Time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a one-month period. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Sleep scores in the ARHL-HA group and the ARHL-nonHA group were assessed using the PSQI before and after intervention, and the difference was calculated.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Other
Registry information
Official study title
Efficacy and Safety of rTMS Combined With HA in the Treatment of Cognitive Decline in Aged Related Hearing Loss: A Single-Center Real-World Study
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2028
- First posted
- Feb 5, 2026
- Registry last updated
- Feb 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.