A Multi-center, Randomized, Double-blind, Pilot Study to Evaluate the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Transitory Improvement of Swallowing Function in Patients With Post-stroke Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Penetration-aspiration Scale (PAS)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women >19 years old
- •patients with stroke confirmed by neuroimaging
- •first-time stroke patients
- •patients in subacute or chronic phases of stroke with 3 weeks or more after onset
- •stroke patients with confirmed dysphagia through Videofluoroscopic Swallowing Study (VFSS).
排除标准
- •patients with recurrent stoke, traumatic brain injury, spine cord injury, and degenerative brain disease, such as Parkinson's disease, etc.
- •patients with deteriorated cognitive function unable to perform the clinical trial as instructed
- •patients with evidence of delirium, confusion, or other impairment of consciousness
- •patients with uncontrolled medical disease or surgical conditions
- •patients ineligible for Transcranial direct current stimulation (due to scalp condition, metallic material at the electrode attachment area, presence of a pacemaker or cochlear implant)
- •patients with previous experience within the last year using a stimulation device similar to the one use in this clinical trial or who have participated in related clinical trials
- •patients with severe neurologic disorder with concomitant major psychiatric disorder such as major depressive disorder and dementia
- •patients with history of uncontrolled epilepsy within 6 months
- •patients with medical contraindications for neuroimaging test, such as MRI;
- •patients who are taken contraindicated medications or require medication changes during the trial period that could influence cognitive/motor function changes via brain activation changes
- •patients who are pregnant, breastfeeding, or planning pregnancy during the trial period
- •patients considered medically ineligible for participation in the present trial beyond the criteria listened above.
研究组 & 干预措施
Optimized transcranial Direct Current Stimulation
Patients receive optimized stimulation obtained from an individualized T1 MRI-based simulation of transcranial direct current stimulation for 30 minutes, once a day for 4 weeks, for a total of 20 sessions.
干预措施: Optimized transcranial Direct Current Stimulation (Device)
Sham transcranial Direct Current Stimulation
Patients receive sham stimulation for 30 minutes, once a day for 4 weeks, for a total of 20 sessions.
干预措施: Sham transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Penetration-aspiration Scale (PAS)
时间窗: Baseline, At 4 weeks from baseline
PAS is a standard scale to assess deglutition in clinical practice and research. It is composed of an 8-point scale used to characterize both the location of airway invasion events and patient's response during video fluoroscopic swallowing studies. The scale design to capture three constructs: depth of airway invasion, material remaining after swallow, and patient's response to aspiration. The scale ranges from score 1 (Material does not enter the airway) to score 8 (Material enters the airway, passes below the level of the vocal folds, and no effort is made to eject)
Functional Oral Intake Scale (FOIS)
时间窗: Baseline, At 4 weeks from baseline
FOIS is a scale used for purposes to assess changes in functional oral intake of food and liquids in patients with dysphagia. FOIS is sensitive to changes in oral intake of food and liquid over time in stroke patients. The scale ranges from level 1 (nothing by mouth) to level 7 (a full unrestricted oral diet)
次要结局
- Penetration-aspiration Scale (PAS)(Baseline, At 2, 4, and 8 weeks from baseline)
- Korean Mann Assessment of Swallowing Ability (K-MASA)(Baseline, At 2, 4, and 8 weeks from baseline)
- Gugging Swallowing Screen(Baseline, At 2, 4, and 8 weeks from baseline)
- Motor-Evoked Potential (MEP)(Baseline, At 2 and 4 weeks from baseline)
- Peak cough flow(Baseline, At 4, and 8 weeks from baseline)
- Functional Oral Intake Scale (FOIS)(Baseline, At 2, 4, and 8 weeks from baseline)
- Videofluoroscopic Dysphagia Scale (VDS)(Baseline, At 2, 4, and 8 weeks from baseline)
- Grade, Roughness, Breathiness, Asthenia and Strain scale(GRBAS scale)(Baseline, At 4, and 8 weeks from baseline)
- Respiratory muscle strength(Baseline, At 4, and 8 weeks from baseline)
- Urimal Test of Articulation and Phonology (U-TAP)(Baseline, At 4, and 8 weeks from baseline)
- modified Rankin Scale (mRS)(Baseline, At 2, 4, and 8 weeks from baseline)
- Eating Assessment Tool-10 (EAT-10)(Baseline, At 2, 4, and 8 weeks from baseline)
- Speech Mechanism Screening Test (SMST)(Baseline, At 4, and 8 weeks from baseline)
- Iowa Oral Performance Instrument (IOPI)(Baseline, At 4, and 8 weeks from baseline)