Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in total number of Vocal fold movements
研究概览
简要总结
Deep Brain Stimulation (DBS) is a neurosurgical procedure used to treat tremors, and dystonia. This study will enroll people who have a form of focal dystonia that affects their vocal cords called Adductor Laryngeal dystonia (ADLD). Participants will undergo Deep Brain Stimulation surgery to treat laryngeal dystonia as part of their clinical care. Before surgery, as part of the study they will have specialized testing to study the movement of the vocal cords, as well as functional magnetic resonance imaging (fMRI). While in the operating room, researchers will examine brain waves to better understand how faulty brain firing patterns lead to dystonia. After surgery, and activation of the deep brain stimulator, participants will repeat speech testing and vocal cord imaging as well as magnetic resonance imaging (MRI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ADLD and ADLD plus tremor, as diagnosed by routine clinical examination by laryngologist, speech language pathologist, and neurologist.
- •Patients undergoing globus pallidus interna (GPi) deep brain stimulation (DBS) for ADLD with tremor
- •Age range of 18-80 years
- •Native speakers of American English will be recruited since there are known differences in voice and neural signals of native and non-native speakers
- •No evidence for dementia as assessed by neurologist.
- •No evidence for severe untreated mood disorder as assessed by neurologist, or as evident on self-report (Beck Depression Inventory-II score > 29, Beck Anxiety Inventory Score >
- •At least 3 months since last botulinum toxin injection and the patients would need to be fully symptomatic with no residual effects of botulinum toxin on voice quality.
排除标准
- •Individuals younger than 18 years and older than 80 years of age.
- •Women who plan to become pregnant during the study period or are currently breastfeeding.
- •Prior history of stroke, brain surgery, or other neurological disorder besides the one under study.
- •Prior laryngeal framework surgeries or other disorders affecting the vocal folds
- •Patients who are asymptomatic due to treatment with botulinum toxin into the vocal folds.
- •Presence of ferromagnetic implants and cardiac implants that would be contraindicated to MRI
- •Gagging or discomfort that would preclude the placement of the endoscope to visualize the larynx
- •Dementia, severe depression or severe anxiety.
- •Any clinical condition or medication judged by the investigators to potentially preclude the patient from safely completing awake brain surgery and research protocols.
研究组 & 干预措施
Deep Brain Stimulation
Voice outcomes and Magnetic resonance imaging will be compared pre- and post-DBS (Deep brain stimulation) in patients with laryngeal dystonia and adductor laryngeal dystonia. The evaluators will be masked for analyzing the voice outcomes pre-and post-DBS
干预措施: Deep Brain Stimulation (Device)
结局指标
主要结局
Change in total number of Vocal fold movements
时间窗: Before surgery, within 24 hours after surgery, 6 -9 months after surgery
Vocal fold movements will be quantified (vibratory breaks + micromotions+ aperiodicities) using high-speed videoendoscopy (HSV) on sustained phonation of the vowel, words, and sentence production. The videoendoscopic recording will be obtained
Change in Acoustic voice recordings
时间窗: Before surgery, within 24 hours after surgery, 6-9 months after surgery
Acoustic voice recordings will be obtained using a microphone. Acoustic measurement of voice (voicing percentage) will be obtained from sustained phonation of the vowel /a/, sentences and reading a paragraph.
Microelectrode recording
时间窗: during surgery
Microelectrode recording is performed routinely during DBS (Deep brain stimulation) surgery. The study procedure will be to record voice simultaneously on sustained phonation of the vowels, syllables, and sentences using the data acquisition system NI USM 6221 with a microphone and high-speed videoendoscopy. Beta and theta band power spectral density will be analyzed as measurements.
次要结局
- Change in Neuropsychological testing: Trails A(Before surgery, and 6-9 months after surgery)
- Change in Voice Handicap Index(before surgery and 6-9 months after surgery)
- Change in Speech Intelligibility(before surgery and 6-9 months after surgery)
- Change in Neuropsychological testin: Trails B(Before surgery, and 6-9 months after surgery)
- Change in Neuropsychological testing: Controlled Oral Word Association Animal fluency(Before surgery, and 6-9 months after surgery)
- Change in Resting state Functional Magnetic Resonance Imaging (fMRI)(before surgery and 6-9 months after surgery)
研究者
Rita R. Patel
Associate Professor, Speech & Hearing Sciences
Indiana University