Functional Neural Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Brain Resting-State Functional Connectivity due to VTS
研究概览
简要总结
Laryngeal dystonia (LD) is a focal dystonia affecting laryngeal muscles, causing involuntary spasms that impair speech production. Recent research demonstrated that non-invasive vibrotactile stimulation (VTS) of the laryngeal area can provide acute symptom relief in up to 57% of patients, with improvements in voice quality and reductions in perceived speech effort lasting from minutes to several days. However, the neural mechanisms underlying this therapeutic effect and the factors determining individual treatment response remain incompletely understood. The objective is to evaluate the acute effects of VTS on voice and speech parameters in participants with LD while characterizing associated changes in brain resting-state networks using magnetic resonance imaging (MRI).
详细描述
To identify the brain networks involved in laryngeal dystonia and any associated changes to this network due to vibro-tactile stimulation (VTS), participants will receive VTS in a controlled laboratory setting for about 20 minutes. They will receive two MRI brain scans, one prior and one after the application of VTS. The scans will take place at the University of Minnesota Center for Magnetic Resonance Research. The total time of the testing procedure that includes receiving VTS and both MRI scans will be approximately 4 hours. This study requires participants to travel Minneapolis.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LD Inclusion Criteria:
- •Diagnosis of laryngeal dystonia previously made by a voice disorder specialist and confirmed by Dr. Misono, UM Otolaryngology.
排除标准
- •Regular intake of benzodiazepines
- •Cognitive impairment: score < 27 on Mini-mental state examination; score > 19 on Beck depression inventory
- •Identifies with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis
- •Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.).
- •Subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
- •Pregnant females (if questionable doubt, self-test with over-the-counter pregnancy kit).
- •Subjects that exhibit noticeable anxiety and/or claustrophobia.
- •Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
- •Subjects who have known conditions which can lead to emergency medical care.
- •Subjects who have been diagnosed by a physician as having a psychiatric disorder, substance abuse, neurological, or cardiovascular disease, had a brain tumor or stroke, started taking chemotherapy or immunomodulatory agents, or had any radiation treatment that could affect the brain.
- •Subjects who have gotten a non-removable piercing or permanent eyeliner.
- •Subjects who have had a head injury that caused the loss of consciousness for more than 30 minutes or have amnesia for more than 24 hours.
- •Anyone with a history of head trauma that may have caused Traumatic Brain Injury (TBI), or some type of metal in the body, either from a medical procedure or an injury.
- •Any subject with a professional or academic link to one of the PIs.
- •We will not enroll vulnerable populations (i.e., fetuses, neonates, pregnant women, children under the age of 18 years, or prisoners).
- •Healthy Controls Inclusion Criteria:
- •Healthy adults, aged 18-75 years with no known neurological or orthopedic deficits that may affect speech motor functions.
- •Healthy Controls Exclusion Criteria:
- •No history of impairments affecting speech or voice function
- •Voice Handicap Index-10 (VHI-10) score above normative cut-off values
- •Regular intake of benzodiazepines.
- •Cognitive impairment: score < 27 on Mini-mental state examination; score > 19 on Beck depression inventory.
- •Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.).
- •Subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
- •Pregnant females (if questionable doubt, self-test with over-the-counter pregnancy kit).
- •Subjects that exhibit noticeable anxiety and/or claustrophobia.
- •Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
- •Subjects who have known conditions which can lead to emergency medical care.
- •Subjects who have been diagnosed by a physician as having a psychiatric disorder, substance abuse, neurological, or cardiovascular disease, had a brain tumor or stroke, started taking chemotherapy or immunomodulatory agents, or had any radiation treatment that could affect the brain.
- •Subjects who have gotten a non-removable piercing or permanent eyeliner.
- •Subjects who have had a head injury that caused the loss of consciousness for more than 30 minutes or have amnesia for more than 24 hours.
- •Anyone with a history of head trauma that may have caused Traumatic Brain Injury (TBI), or some type of metal in the body, either from a medical procedure or an injury.
- •Any subject with a professional or academic link to one of the PIs.
- •We will not enroll vulnerable populations (i.e., fetuses, neonates, pregnant women, children under the age of 18 years, or prisoners).
研究组 & 干预措施
Laryngeal Dystonia Patients
干预措施: Vibrotactile Stimulation (VTS) (Device)
Healthy Controls
干预措施: Vibrotactile Stimulation (VTS) (Device)
结局指标
主要结局
Change in Brain Resting-State Functional Connectivity due to VTS
时间窗: Hour 2.5
Resting state functional connectivity (rs-fMRI) refers to the brain's activity when a person is not engaged in any specific task. It measures spontaneous fluctuations in the blood oxygen level-dependent (BOLD) signal, which indicates brain activity. The rs-fMRI will be obtained twice before and after receiving VTS and the change in rs-fMRI will be obtained.
次要结局
- Cepstral Peak Prominence Smoothed(Hour 0.5)
- Changes in Perceived Speech Effort(Hour 0.5)
- Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score(Hour 0.5)
- Voice Handicap Index(Hour 0.5)