Stimulation of the Thalamus to Ameliorate Parkinsonian Speech Disfluencies: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3
- 主要终点
- Change of One-Page Suttering Assessment from Baseline to Post-Operation
研究概览
简要总结
The research team aims to provide evidence of Parkinsonian (PD) Stutter management by addressing the primary neurological issue in this disorder using Deep Brain Stimulation (DBS). The team proposes to perform unilateral DBS on 3 patients with PD stutter refractory to intensive speech therapy, to determine a response in their PD stutter. The assessments will be double-blinded. The investigators will use the outcome of this case series to determine the feasibility and details of a larger randomized controlled trial.
详细描述
Purpose: The purpose is to assess if dominant thalamic Deep Brain Stimulation (DBS) is an effective treatment for Parkinsonian stutter. Functional magnetic resonance imaging (MRI) will detect brain dominance before surgery. The research team will assess whether dominant thalamic DBS is preferable for stutter treatment.
Hypothesis: The research team hypothesizes that dominant thalamic neuromodulation with DBS effectively treats PD stutter.
Justification:
The investigators initially began investigating the possibility of treatment of Stutter with DBS when they had a patient whose stutter serendipitously improved following thalamic DBS for tremor. The patient had severe tremor requiring bilateral thalamic DBS; he coincidentally had stutter. Post-operatively, the patient noted that he had had marked improvement in his tremor as well as his stutter. This prompted a literature search, where the investigators found that this has previously been reported in one other patient. Previous investigations of spasmodic dysphonia show that speech (similar to language) is lateralized in most patients, and that unilateral treatment of the dominant hemisphere is as beneficial as bilateral treatment.
Objectives: The objective is to perform a case series of three patients to assess feasibility and determine design of a future, larger study. If there is an appreciable reduction in stuttering with dominant stimulation, a larger unilateral (dominant) thalamic study can be undertaken. The magnitude of effect determined by this pilot trial will allow for a power calculation for the future study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between the ages of 19 and 80 years old
- •Individuals with persistent PD stutter
排除标准
- •Patients with mild symptoms.
- •Patients who have a neurodegenerative disease.
- •Patients with a bleeding diathesis.
- •non English speaking patients
结局指标
主要结局
Change of One-Page Suttering Assessment from Baseline to Post-Operation
时间窗: One-Page Stutter Assessment will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-ON
Objectively assesses individual's stutter. Divide the number of instances of stuttering by the number of syllables in the sample and multiply by 100 to obtain the percentage of stuttered syllables.
次要结局
- Change of Voice Related Quality of Life (VRQoL) from Baseline to Post-Operation(V-RQOL will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-ON)
- Change of Overall Assessment of the Speaker's Experience of Stuttering (OASES) from Baseline to Post-Operation(OASES will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-ON)
研究者
Christopher Honey
Professor of Neurosurgery
University of British Columbia