Effects of Transcutaneous Stimulation of the Auricular Branch of the Vagus Nerve in Parkinson´s Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 2
研究概览
简要总结
This study aims to determine whether electrical stimulation of the ear, when combined with physical and speech therapy, can improve symptoms in subjects diagnosed with Parkinson´s disease, by comparing two different application sites.
Each subject will undergo an initial in-person screening and provide consent before participating in the study.
The main questions to answer are:
- Does transcutaneous electrical nerve stimulation (tVNS) in the ear paired with physical and speech therapy improve speech and voice-related problems, airway protection, salivation, and swallowing?
- Does tVNS paired with physical and speech therapy improve tremor, walking speed, and balance in people with PD?
- Does tVNS paired with physical and speech therapy improve heart rate and heart rate variability in people with PD?
- Do its effects persist at 8 weeks?
Participants will:
Attend 12 rehabilitation sessions over 4 weeks (three per week). During each session, participants received either active or sham tVNS, accompanied by speech therapy (once per week), physical therapy (once per week), or conducted alone (once per week).
Undergo speech, voice, swallowing, respiratory, gait, balance, tremor, heart rate variability, and cognitive testing, as well as questionnaires regarding the quality of life, before and after treatment.
Return for a follow-up visit eight weeks after therapy to check how long the effects last.
详细描述
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease. Most people with PD will experience dysfunction of the autonomic nervous system (ANS), although the severity of this dysfunction can vary widely, affecting both physical and mental well-being. Symptoms are typically classified as motor or non-motor. Prominent motor symptoms of PD include bradykinesia, rigidity, tremor, and abnormalities in gait, balance, and posture. These symptoms are associated with falls and have a very negative impact on quality of life. In addition, impaired fine motor skills, combined with respiratory and other problems, significantly affect voice, speech, and swallowing, as well as other non-motor disorders, such as neuropsychiatric, sleep, sensory, and digestive disorders.
This study is a double-blind, randomized, controlled trial designed to evaluate the efficacy of transcutaneous auricular vagus nerve stimulation on the motor and non-motor effects of Parkinson´s Disease (PD). Investigators will recruit up to 46 patients. The volunteers will be randomized by sex and the Hoehn and Yahr stage. Clinical information and, specifically, Unified Parkinson's Disease Rating Scale (UPDRS) -III (section III) will be assessed initially.
The primary variable of the study will be voice variables, such as volume, jitter, and shimmer. The remaining dependent variables will be other voice and acustic measures; the presence and severity of dysphagia; the presence and severity of xerostomia and sialorrhea; swallowing efficiency, peak cough flow; the level of tremor; the severity of gait dysfunction; balance; cognitive ability regarding concentration and response inhibition; heart rate and heart rate variability; quality of life in PD; adverse effects; and the degree of effectiveness of blinding.
Over the course of 4 weeks, participants will receive 30-minute stimulation sessions three times weekly, along with physiotherapy and speech therapy once per week. One group will be assigned to stimulation in the cymba concha (where the vagus nerve is placed) and the other (sham) in the earlobe.
Data collection will occur at baseline (T0), post-intervention (T1- 4 weeks), and 8 weeks after finishing the intervention (T2), except for the intensity required to administer electrical stimulation and adverse effects, which will be studied during the whole intervention. Tolerance will be assessed on day 1 of stimulation and on day 12 (4 weeks). Statistical analyses will employ mixed-model approaches to evaluate changes in outcome measures over time and between interventions.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being a member of the Association or be interested in joining;
- •Idiopathic PD diagnosis, stages 2-3 according to the Hoehn & Yahr scale; confirmed by neurologist
- •Ability to walk independently for at least 1 minute ant turn 180° without assistance;
- •Exhibiting symptoms of hypokinetic dysarthria;
- •On stable dopaminergic therapy for at least 1 month prior to the experiment
排除标准
- •Any contraindication for taVNS (e.g., ear lesions, pacemakers, defibrillators, or other electronic devices)
- •Previous vagotomy or previous application of electrical stimulation to the ear or brain, or treatment with high-intensity focused ultrasound (HIFU)
- •Voice or speech disorders caused by other medical conditions
- •MoCA score below 21
- •Psychotic symptoms or hallucinations; a diagnosis of psychiatric illness
- •Systolic blood pressure above 160 mm Hg, and diastolic blood pressure above 100 mm Hg
- •Inability to attend sessions;
- •Concomitant neurological, orthopaedic, cardiac, respiratory or active medical/oncological condition that would affect participation
研究组 & 干预措施
Active tVNS paired with conventional Speech Therapy and Physical Therapy
Participants in this arm will receive transcutaneous electrical stimulation applied to the concha of the left ear for 30 minutes, three times a week, over a 4-week period. This location is known to be innervated by the auricular branch of the vagus nerve. In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.
干预措施: Conventional Speech Therapy (Other)
Sham tVNS paired with Speech Therapy and Physical Therapy
Participants in this arm will receive the same transcutaneous electrical stimulation as the active group, but applied to the earlobe, a site not innervated by the vagus nerve. The procedure, the appearance of the device, and the parameters are identical to those of the active condition to maintain participant blinding. In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.
干预措施: Conventional Physical therapy (Other)
Sham tVNS paired with Speech Therapy and Physical Therapy
Participants in this arm will receive the same transcutaneous electrical stimulation as the active group, but applied to the earlobe, a site not innervated by the vagus nerve. The procedure, the appearance of the device, and the parameters are identical to those of the active condition to maintain participant blinding. In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.
干预措施: Conventional Speech Therapy (Other)
Active tVNS paired with conventional Speech Therapy and Physical Therapy
Participants in this arm will receive transcutaneous electrical stimulation applied to the concha of the left ear for 30 minutes, three times a week, over a 4-week period. This location is known to be innervated by the auricular branch of the vagus nerve. In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) of Vagus Nerve (Device)
Active tVNS paired with conventional Speech Therapy and Physical Therapy
Participants in this arm will receive transcutaneous electrical stimulation applied to the concha of the left ear for 30 minutes, three times a week, over a 4-week period. This location is known to be innervated by the auricular branch of the vagus nerve. In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.
干预措施: Conventional Physical therapy (Other)
Sham tVNS paired with Speech Therapy and Physical Therapy
Participants in this arm will receive the same transcutaneous electrical stimulation as the active group, but applied to the earlobe, a site not innervated by the vagus nerve. The procedure, the appearance of the device, and the parameters are identical to those of the active condition to maintain participant blinding. In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.
干预措施: Sham Transcutaneous Electrical Stimulation of Vagus Nerve (Device)
研究者
Alicia Martínez Rodríguez
Lecturer; Faculty of Physical Therapy. Researcher; Psychosocial Intervention and Functional Rehabilitation Group
Universidade da Coruña