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Senile DeadnessNCT07389213

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

A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with Senile Deadness, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Senile Deadness
What is being tested?
repetitive Transcranial Magnetic Stimulation (rTMS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
1 siteChina
Study dates
1 May 2025to 31 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yang Haidi, PhD contact

13178821663

yanghaidi1978@163.com

China1 site, 1 recruiting
  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 5100000

    Haidi Yang, PhD, 020-81332449, yanghaidi1978@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Senile Deadness
Being tested
repetitive Transcranial Magnetic Stimulation (rTMS)
Keywords
senile deadness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07389213
Study groupRoleWhat they receive
ARHL-nonHA groupExperimentalThis 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.
Receives: Device: repetitive Transcranial Magnetic Stimulation (rTMS)
ARHL-HA groupExperimentalThis 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.
Receives: Device: repetitive Transcranial Magnetic Stimulation (rTMS)
HC groupNo interventionAged 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)
  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start1 May 2025
  3. Primary completion23 Jul 2026 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
189 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07389213
Sponsor's protocol ID
SYSKY-2025-525-01
Status last verified
Jul 2025
First submitted
25 Nov 2025
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with Senile Deadness, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yang Haidi, PhD (13178821663, yanghaidi1978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment(MoCA ) improvement value (time frame: Baseline、Post-intervention 2 weeks and Post-intervention 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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