Thalamic Deep Brain Stimulation for Spasmodic Dysphonia: A Prospective, Randomized, Double-Blinded, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Unified Spasmodic Dysphonia Rating Scale (USDRS)
研究概览
简要总结
Laryngeal Dystonia (LD), also commonly referred to as spasmodic dysphonia, is a neurological voice disorder characterized by involuntary dystonic contractions of the laryngeal muscles. Current treatments such as botox and voice therapy only provide temporary relief and thus, the investigators are exploring new strategies to provide long-term, sustained improvement.
Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the implantation of electrodes to deliver electrical stimuli to specific brain regions. It is the standard surgical treatment for many other movement disorders such as Parkinson's disease, essential tremor, and primary dystonia. This trial has been designed to test the hypothesis that DBS can improve the vocal dysfunction of LD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- 否
入选标准
- •Clinically diagnosed isolated laryngeal dystonia (adductor spasmodic dysphonia)
- •Able to give informed consent
- •Patients who fall into the age range of 18-75 years old
- •Patients with inadequate medical and BTX management of spasmodic dysphonia
排除标准
- •Dystonia present in other body parts (i.e- eyes, neck, limbs) in addition to larynx
- •History of laryngeal denervation surgery for spasmodic dysphonia
- •History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms) that may account for dystonia or essential tremor.
- •History or evidence of ongoing psychiatric or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease).
- •Incompetent adults or those unable to communicate.
结局指标
主要结局
Unified Spasmodic Dysphonia Rating Scale (USDRS)
时间窗: After the first 6 months, the participants completed the USDRS twice (once per crossover).
Assessments of spasmodic dysphonia using a standardized spasmodic dysphonia rating scale were done pre-operatively, blinded DBS ON, blinded DBS OFF, and open DBS ON. Voice recording taken of each patient reading standardized sentences were blinded and evaluated by two speech language pathologists. The scale ranges from 0-7, with lower scores being better and higher scores being worse.
Voice-Related Quality of Life
时间窗: After the first 6 months, the participants completed the V-RQoL twice (once per crossover).
Double-blinded assessments of voice-related quality of life with DBS ON/OFF were conducted using the V-RQoL for Spasmodic Dysphonia. The V-RQoL is a questionnaire that measures a patient's voice related quality of life. The scale ranges from 0-50, with higher scores representing a lower quality of life with respect to voice.
次要结局
- Beck's Depression Inventory Scale(All participants completed the BDI-II once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).)
- Montreal Cognitive Assessment Scale (MoCA)(All participants completed the MoCA once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).)
- Voice-Handicap Index(All participants completed the VHI once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).)
研究者
Christopher Honey
Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders
University of British Columbia