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

NCT07389213 | Recruiting

• 1 other identifier: SYSKY-2025-525-01
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Senile Deadness

Keywords

senile deadness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Mini-Mental State Examination(MMSE) improvement value

  Baseline、Post-intervention 2 weeks and Post-intervention 1 month

• Pure-Tone Average(PTA) improvement value

  Baseline、Post-intervention 2 weeks and Post-intervention 1 month

• Speech Reception Threshold(SRT) improvement value

  Baseline、Post-intervention 2 weeks and Post-intervention 1 month

• Trail Making Test Part A (TMT-A) improvement value

  Baseline、Post-intervention 2 weeks and Post-intervention 1 month

• Trail Making Test Part B (TMT-B) improvement value

  Baseline、Post-intervention 2 weeks and Post-intervention 1 month

Study Arms (3)

ARHL-nonHA group

EXPERIMENTAL

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)

ARHL-HA group

EXPERIMENTAL

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)

HC group

NO INTERVENTION

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.

Interventions

repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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.

ARHL-HA group; ARHL-nonHA group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 5100000, China

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Yang Haidi, PhD

  SunYatSunU2H

  STUDY CHAIR

Central Study Contacts

Yang Haidi, PhD

CONTACT

13178821663; yanghaidi1978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 189 participants will be enrolled according to inclusion and exclusion criteria, including the ARHL-nonHA group, the ARHL-HA group, and the HC group. The three groups will undergo audiological assessments (PTA, SRT), cognitive function assessments (MoCA, MMSE, TMT-A, TMT-B, DST, SCWT), depression and sleep assessments (GDS-15, HAMD-24, PSQI), and imaging assessments (resting-state EEG, structural sMRI, resting-state functional rs-fMRI, task-based functional task-fMRI). The ARHL-nonHA and ARHL-HA groups will receive two courses of high-frequency rTMS stimulation, with each course lasting 14 days, one session per day, and each session lasting 9 minutes. Audiological, cognitive, depression and sleep, and imaging assessments will be performed on the ARHL-nonHA and ARHL-HA groups at 14 days and 1 month after the intervention, and the improvement values of the above indicators will be obtained.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: February 5, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 23, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 5, 2026

Record last verified: 2025-07

Locations

CN (1)