Synergistic Effects of Combined Repetitive Transcranial Magnetic Stimulation and Olfactory Training on Chemosensory Recovery in Parkinson's Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
Background:
Olfactory and gustatory impairments are common clinical manifestations in patients with neurodegenerative conditions like Parkinson's disease. These chemosensory deficits significantly impact the quality of life, often preceding motor symptoms. Currently, there is a need for effective non-invasive interventions to improve sensory recovery.
Objective:
The primary objective of this study is to evaluate the therapeutic efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) combined with olfactory training in restoring chemosensory function. We aim to determine whether this combined approach provides superior outcomes compared to individual therapies or standard care.
Methods:
This clinical trial involves 120 patients diagnosed with Parkinson's disease. Participants will be randomized into four groups to receive either combined rTMS and olfactory training, isolated rTMS, isolated olfactory training, or a control intervention. The recovery of olfactory function will be measured using validated sensory testing tools (such as Sniffin' Sticks) and Electrogustometry (EGM) to assess neural pathway improvement.
Conclusion/Significance:
This study aims to provide evidence-based insights into non-invasive neurological rehabilitation for chemosensory dysfunction. The findings may help optimize personalized treatment protocols for patients suffering from sensory impairment, potentially enhancing their overall cognitive and sensory quality of life.
详细描述
Study Design and Patient Selection:
This is a prospective, randomized, four-arm clinical study. A total of 120 patients meeting the inclusion criteria for Parkinson's disease-related chemosensory dysfunction are enrolled. Subjects are randomized using a 1:1:1:1 ratio.
Intervention Protocols:
rTMS Protocol: The intervention group receives high-frequency (10 Hz) stimulation targeted at the cortical regions associated with olfactory processing. The protocol consists of 2000 pulses per session.
Olfactory Training: Participants perform structured olfactory training utilizing standardized odorant sets, conducted twice daily over the 12-week study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are blinded to their assigned intervention arm, as they receive either active rTMS or sham stimulation, which are delivered using an identical setup. Outcome assessors, who perform the chemosensory evaluations (e.g., Sniffin' Sticks test), are also blinded to the group assignment of each participant to minimize assessment bias. Investigators involved in the analysis are masked to the group identities until the data collection phase is finalized.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 40 and 75 years.
- •Confirmed diagnosis of idiopathic Parkinson's disease (PD) according to the Movement Disorder Society (MDS) clinical diagnostic criteria.
- •Confirmed olfactory dysfunction validated by the Sniffin' Sticks test at baseline (defined as a composite TDI score ≤ 30.5 for hyposmia and < 16.0 for functional anosmia).
排除标准
- •Presence of cranial metal implants or cardiac pacemakers (absolute contraindications for rTMS).
- •Pregnancy.
- •Severe psychiatric disorders.
- •Advanced dementia.
- •History of nasal polyps or active sinusitis that could mechanically obstruct olfactory pathways.
研究组 & 干预措施
rTMS and Olfactory Training
Participants in this group receive high-frequency (10 Hz) rTMS stimulation (2000 pulses per session) targeted at cortical olfactory regions, combined with a daily structured olfactory training protocol over the 12-week study period.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
rTMS and Olfactory Training
Participants in this group receive high-frequency (10 Hz) rTMS stimulation (2000 pulses per session) targeted at cortical olfactory regions, combined with a daily structured olfactory training protocol over the 12-week study period.
干预措施: Structured Olfactory Training (Behavioral)
Experimental: rTMS alone
Participants in this group receive high-frequency (10 Hz) rTMS stimulation (2000 pulses per session) targeted at cortical olfactory regions, without the concurrent structured olfactory training protocol, over the 12-week study period.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Active Comparator: Olfactory Training alone
Participants in this group perform a structured 12-week olfactory training protocol twice daily using standardized odorants, without receiving any active rTMS stimulation.
干预措施: Structured Olfactory Training (Behavioral)
Sham Comparator: Control Group
Participants in this group receive sham rTMS stimulation (using a deactivated coil setup) without any structured olfactory training for the 12-week study duration.
干预措施: Sham rTMS (Device)
结局指标
主要结局
未指定
次要结局
- Change in Sniffin' Sticks Odor Threshold Score from Baseline to Week 12(Baseline and 12 weeks.)
- Change in Sniffin' Sticks Odor Discrimination Score from Baseline to Week 12(Baseline and 12 weeks.)
- Change in Sniffin' Sticks Odor Identification Score from Baseline to Week 12(Baseline and 12 weeks.)
研究者
Mustafa Baran
Assistant Professor
Batman University