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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment(MoCA ) improvement value
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
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.
干预措施: repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
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.
结局指标
主要结局
Montreal Cognitive Assessment(MoCA ) improvement value
时间窗: 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.
次要结局
- 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)
- Digit Span Test (DST)improvement value(Baseline、Post-intervention 2 weeks and Post-intervention 1 month)
- Stroop Color and Word Test (SCWT) improvement value(Baseline、Post-intervention 2 weeks and Post-intervention 1 month)
- 15-item Geriatric Depression Scale (GDS-15) improvement value(Baseline、Post-intervention 2 weeks and Post-intervention 1 month)
- 24-item Hamilton Depression Rating Scale (HAMD-24)improvement value(Baseline、Post-intervention 2 weeks and Post-intervention 1 month)
- Pittsburgh Sleep Quality Index (PSQI) improvement value(Baseline、Post-intervention 2 weeks and Post-intervention 1 month)