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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Senile Deadness
• Intervention / Treatment: Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 189
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Haidi, PhD; Phone Number: 13178821663; Email: yanghaidi1978@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 5100000
      • Recruiting
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Contact: Haidi Yang, PhD; Phone Number: 020-81332449; Email: yanghaidi1978@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARHL-nonHA group; This study will use repetitive transcranial magnetic stimulation (rTMS) as an intervention. Participants will be right-handed Chinese individuals aged between 50 and 85 years, diagnosed with moderate to severe age-related hearing loss (pure-tone average PTA of the better ear ranging from 35 to 79 dB), meeting the diagnostic criteria outlined in the 2019 expert consensus. Eligible participants must have at least 6 years of education and be able to complete all assessments in the Chinese version.	Device: 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.
Experimental: ARHL-HA group; This study will use repetitive transcranial magnetic stimulation (rTMS) as an intervention. Participants will be right-handed Chinese individuals aged between 50 and 85 years, diagnosed with moderate to severe age-related hearing loss (pure-tone average PTA of the better ear ranging from 35 to 79 dB).Participants must have been wearing hearing aids for more than six months and use them for over 7.2 hours daily. Eligible participants must have at least 6 years of education and be able to complete all assessments in the Chinese version.	Device: 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.
No Intervention: HC group; Aged between 50 and 85 years, with no gender restriction; pure-tone average (PTA) ≤25 dB HL in the better ear; Chinese nationality, able to complete all Chinese-version assessments; right-handed; and with at least 6 years of education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment(MoCA ) improvement value	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.	Baseline、Post-intervention 2 weeks and Post-intervention 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination(MMSE) improvement value	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.	Baseline、Post-intervention 2 weeks and Post-intervention 1 month
Pure-Tone Average(PTA) improvement value	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.	Baseline、Post-intervention 2 weeks and Post-intervention 1 month
Speech Reception Threshold(SRT) improvement value	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.	Baseline、Post-intervention 2 weeks and Post-intervention 1 month
Trail Making Test Part A (TMT-A) improvement value	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.	Baseline、Post-intervention 2 weeks and Post-intervention 1 month
Trail Making Test Part B (TMT-B) improvement value	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.	Baseline、Post-intervention 2 weeks and Post-intervention 1 month
Digit Span Test (DST)improvement value	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.	Baseline、Post-intervention 2 weeks and Post-intervention 1 month
Stroop Color and Word Test (SCWT) improvement value	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.	Baseline、Post-intervention 2 weeks and Post-intervention 1 month
15-item Geriatric Depression Scale (GDS-15) improvement value	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.	Baseline、Post-intervention 2 weeks and Post-intervention 1 month
24-item Hamilton Depression Rating Scale (HAMD-24)improvement value	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.	Baseline、Post-intervention 2 weeks and Post-intervention 1 month
Pittsburgh Sleep Quality Index (PSQI) improvement value	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.	Baseline、Post-intervention 2 weeks and Post-intervention 1 month

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Chair: Yang Haidi, PhD, SunYatSunU2H

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): July 23, 2026
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: senile deadness
• Additional Relevant MeSH Terms: Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: SYSKY-2025-525-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No