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

Official 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

Overview

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.

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.

Interventions

• 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

Primary outcome measures

• Montreal Cognitive Assessment(MoCA ) improvement value [Time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month]

Secondary outcome measures (10)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07389213 · SYSKY-2025-525-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗