Individualized Transcranial Temporal Interference Stimulation Targeting the Dentato-Thalamo-Cortical Pathway for Post-Stroke Dysphagia: A Randomized, Double-Blind, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in Penetration-Aspiration Scale Score
研究概览
简要总结
The goal of this clinical trial is to learn whether individualized transcranial temporal interference stimulation can improve swallowing in adults with swallowing difficulties after an ischemic stroke. It will also evaluate the safety and tolerability of this stimulation. The main questions it aims to answer are:
- Does active temporal interference stimulation combined with swallowing rehabilitation improve swallowing safety more than sham stimulation combined with the same rehabilitation?
- What side effects or medical problems occur during and after the stimulation?
Researchers will compare active stimulation with sham stimulation, which uses the same equipment but does not deliver sustained therapeutic stimulation.
Participants will:
- Receive active or sham stimulation for 30 minutes per session, 5 days per week for 2 weeks
- Receive the same task-specific swallowing rehabilitation after each stimulation session
- Undergo swallowing assessments, brain imaging, and neurophysiological testing
- Attend follow-up assessments 4 and 12 weeks after treatment
详细描述
Post-stroke dysphagia is associated with aspiration, pneumonia, malnutrition, prolonged hospitalization, functional dependence, and mortality. Although conventional swallowing rehabilitation can improve swallowing function, recovery is often incomplete. Transcranial temporal interference stimulation (tTIS) is an investigational, noninvasive neuromodulation technique that uses intersecting high-frequency electrical currents to generate a lower-frequency stimulation envelope within a selected deep-brain target.
This prospective, single-center, randomized, double-blind, sham-controlled trial will enroll 88 adults with dysphagia following a first unilateral supratentorial ischemic stroke. Participants will be randomly assigned in a 1:1 ratio to receive active or sham tTIS. Both groups will receive identical task-specific swallowing rehabilitation. The stimulation target will be the cerebellar dentate nucleus contralateral to the cerebral lesion. Individual structural magnetic resonance imaging and finite-element electric-field modelling will be used to optimize electrode placement and the current ratio for each participant.
The active intervention will use two carrier frequencies of 2000 and 2020 Hz to generate a 20-Hz envelope. Each stimulation session will last 30 minutes and will be followed by standardized swallowing rehabilitation. Participants will receive 10 weekday sessions over 2 consecutive weeks. The sham group will undergo the same procedures and treatment schedule without sustained active stimulation.
Clinical assessments will be conducted at baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up. Videofluoroscopic swallowing studies will be used to evaluate swallowing safety and efficiency. Neurophysiological testing and resting-state functional magnetic resonance imaging will be used to explore whether treatment-related swallowing improvement is associated with changes in corticobulbar excitability and functional connectivity within the dentato-thalamo-cortical swallowing network.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, swallowing therapists, clinical outcome assessors, imaging personnel, and statisticians will be unaware of treatment allocation. The stimulation device will display only a coded treatment mode. The stimulation operator cannot be masked because the operator must select and administer the assigned active or sham program. The operator will not participate in swallowing rehabilitation, outcome assessment, data management, or statistical analysis and will use standardized interactions with participants.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •First-ever unilateral supratentorial ischemic stroke confirmed by computed tomography or magnetic resonance imaging
- •Stroke onset 14 to 90 days before randomization
- •Oropharyngeal dysphagia confirmed by videofluoroscopic swallowing study, with a worst Penetration-Aspiration Scale score of 3 to 7 during prespecified standardized bolus trials
- •Medically stable and able to remain seated during stimulation and swallowing rehabilitation
- •Able to follow one-step commands, directly or with supported communication
- •Written informed consent provided by the participant or a legally authorized representative
排除标准
- •Brainstem or primary cerebellar stroke, bilateral cerebral infarction, previous symptomatic stroke, intracranial hemorrhage, or progressive neurological disease
- •Pre-stroke dysphagia, structural oropharyngeal disease, previous treatment for head and neck cancer, or another condition that independently explains dysphagia
- •Tracheostomy, current mechanical ventilation, uncontrolled pneumonia, severe hypoxemia, or hemodynamic instability
- •History of epilepsy, seizure after the index stroke, unexplained loss of consciousness, or current use of medication considered to confer an unacceptable seizure risk
- •Intracranial metallic material, implanted electronic device, cochlear implant, or another contraindication to transcranial temporal interference stimulation, magnetic resonance imaging, or transcranial magnetic stimulation
- •Severe cognitive, behavioral, or language impairment that prevents participation despite supported communication
- •Pregnancy or breastfeeding
- •Major scalp disease at the planned electrode sites
- •Participation in another interventional clinical trial
- •Any other condition considered unsafe or unsuitable by the investigator
研究组 & 干预措施
Active tTIS Group
Participants will receive individualized active transcranial temporal interference stimulation targeting the cerebellar dentate nucleus contralateral to the cerebral lesion, followed by standardized task-specific swallowing rehabilitation. Treatment will be administered for 30 minutes per session, 5 sessions per week for 2 consecutive weeks, for a total of 10 sessions.
干预措施: Active Transcranial Temporal Interference Stimulation (Device)
Active tTIS Group
Participants will receive individualized active transcranial temporal interference stimulation targeting the cerebellar dentate nucleus contralateral to the cerebral lesion, followed by standardized task-specific swallowing rehabilitation. Treatment will be administered for 30 minutes per session, 5 sessions per week for 2 consecutive weeks, for a total of 10 sessions.
干预措施: Standardized Task-Specific Swallowing Rehabilitation (Behavioral)
Sham tTIS Group
Participants will receive sham transcranial temporal interference stimulation followed by the same standardized task-specific swallowing rehabilitation. The sham procedure will use the same device, electrode montage, session duration, and ramp sensations as active stimulation but will not deliver sustained active stimulation. Treatment will be administered 5 sessions per week for 2 consecutive weeks, for a total of 10 sessions.
干预措施: Sham Transcranial Temporal Interference Stimulation (Device)
Sham tTIS Group
Participants will receive sham transcranial temporal interference stimulation followed by the same standardized task-specific swallowing rehabilitation. The sham procedure will use the same device, electrode montage, session duration, and ramp sensations as active stimulation but will not deliver sustained active stimulation. Treatment will be administered 5 sessions per week for 2 consecutive weeks, for a total of 10 sessions.
干预措施: Standardized Task-Specific Swallowing Rehabilitation (Behavioral)
结局指标
主要结局
Change in Penetration-Aspiration Scale Score
时间窗: Baseline and immediately after the 2-week intervention
The Penetration-Aspiration Scale (PAS) will be scored from videofluoroscopic swallowing study recordings using standardized boluses. Scores range from 1 to 8, with higher scores indicating greater airway invasion and worse swallowing safety. The worst PAS score across the prespecified bolus trials will be used. The primary outcome is the change in PAS score from baseline to immediately after the 2-week intervention.
次要结局
- Change in Dynamic Imaging Grade of Swallowing Toxicity(Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up)
- Change in Functional Oral Intake Scale Score(Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up)
- Change in Standardized Swallowing Assessment Score(Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up)
- Change in Swallowing Quality of Life Questionnaire Score(Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up)
- Change in Maximum Hyoid Displacement(Baseline and immediately after the 2-week intervention)
- Change in Pharyngeal Transit Time(Baseline and immediately after the 2-week intervention)
- Incidence of Aspiration Pneumonia(From randomization through the 12-week follow-up)
- Incidence of Adverse Events(During the 2-week intervention and through the 12-week follow-up)
研究者
Xing-Chen Zhou
Prof.
First Affiliated Hospital of Zhejiang University