Clinical Study on the Safety and Efficacy of Temporal Interference Stimulation in the Treatment of Post-Stroke Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Aphasia Battery of Chinese (ABC,comprising spontaneous speech, auditory comprehension, repetition, naming, reading, writing, structural and spatial functions, application and calculation)
研究概览
简要总结
Neurological disorders encompass a wide variety of diseases, including congenital and neurodevelopmental disorders, cerebrovascular and neurodegenerative diseases, nervous system infections, neuroimmune diseases, neuromuscular or peripheral nervous system disorders, traumatic injuries, and tumor-related neurological conditions, with diverse symptomatic manifestations. The etiology, symptoms, and disease courses of these disorders vary significantly, severely impacting human health and social development, and have become a critical global public health issue. Some neurological disorders can lead to lifelong disability or high mortality rates, while others remain poorly understood, lacking effective treatments or cures.
Post-stroke aphasia (PSA) is an acquired language impairment caused by ischemic or hemorrhagic injuries to the central nervous system. Its clinical manifestations are diverse, potentially affecting spontaneous speech, auditory comprehension, repetition, naming, reading, and writing abilities, among other aspects. Statistics indicate that over 16 million people worldwide suffer from stroke each year, with approximately 38% of survivors experiencing aphasia. The prognosis for this condition is concerning, as more than 40% of patients still exhibit significant language impairments one year after the stroke, with some even facing lifelong effects. The large patient population, significant communication barriers, and poor prognosis severely diminish patients' quality of life, significantly increasing their risk of emotional disorders such as depression and social isolation. This poses a substantial challenge to family caregiving and public health systems. Therefore, the development of non-invasive and effective novel therapeutic approaches holds substantial scientific and societal importance.
Temporal interference stimulation (TI) technology represents a breakthrough in achieving non-invasive deep brain stimulation. This technology is based on the interference phenomenon, utilizing two pairs of surface electrodes to simultaneously apply sinusoidal wave stimuli at 2 kHz and 2.01 kHz. Two cortical regions are exposed to electric fields of 2 kHz or 2.01 kHz, and an interference electric field is generated in the brain region where these two fields overlap, with its envelope oscillating at 10 Hz. This technology has already been applied in the treatment of conditions such as depression, Parkinson's disease, and disorders of consciousness. The primary objective of this study is to explore the effects of TI intervention on deep brain regions, particularly on motor and non-motor related brain networks and functions in patients with neurological disorders, especially post-stroke aphasia. This research aims to provide a potential new approach for improving the clinical symptoms of these patients.
详细描述
This study plans to recruit 40 patients with neurological disorders and randomly assign them to either a real stimulation treatment group or a sham stimulation treatment group (20 patients per group). The real stimulation treatment group will receive treatment using Temporal Interference Stimulation (TIS) technology. The current frequencies are intended to be 1400 Hz and 1430 Hz. The stimulation duration is 30 minutes; administered once daily for 10 consecutive days. The control group will receive sham stimulation. The sham stimulation group will have the same electrode placement, current intensity, and frequency settings as the TIS group, but without eliciting physiological effects. Randomization will be performed to blind both the patients and the assessors. The order of stimulation targets will be randomized between subjects, while the order of stimulation targets for the same subject will remain consistent throughout the treatment course. Treatment will be administered for 10 consecutive days. Both groups will receive either real or sham stimulation paired simultaneously with standard Speech and Language Therapy (SLT).The observation indicators will be the changes in scores from baseline to post-treatment and follow-up on the following assessments: Western Aphasia Battery (WAB, including fluency and information content), Aphasia Battery of Chinese (ABC,comprising spontaneous speech, auditory comprehension, repetition, naming, reading, writing, structural and spatial functions, application and calculation), Verbal Fluency Test (VFT), Language Assessment Manual (Including True Word Auditory Repetition, Picture Naming, Non-Word Auditory Repetition, Word Reading, Verb-Noun-Picture Matching, Writing), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Activities of Daily Living (ADL) scale, Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), Brunnstrom stages of stroke recovery, and simplified Fugl-Meyer Assessment of motor function (FMA).
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, Outcomes Assessor)
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
- •Diagnosed with post-stroke aphasia;
- •Right-handed;
- •Native Chinese speaker with comprehension of Mandarin;
- •Aged 18-80 years;
- •Complete relevant assessment and imaging data;
- •Informed consent obtained from the patient and their family.
排除标准
- •Cerebellar involvement in the stroke lesion, and incomplete scanning of cerebellar structures;
- •Severe dysarthria;
- •Concurrent epilepsy with occasional seizures;
- •Implanted pacemaker or deep brain stimulator;
- •History of brain tissue resection for prior lesions such as brain tumours or brain abscesses;
- •Other severe psychiatric disorders.
研究组 & 干预措施
real stimulation
Temporal interference stimulation (TI) will be applied for treatment; the current frequencies will be set at 1400 Hz and 1430 Hz; stimulation duration will be 30 minutes per session, once daily for 10 consecutive days.During the stimulation, they underwent standardized speech and language therapy (SLT) simultaneously.
干预措施: speech and language therapy (Behavioral)
real stimulation
Temporal interference stimulation (TI) will be applied for treatment; the current frequencies will be set at 1400 Hz and 1430 Hz; stimulation duration will be 30 minutes per session, once daily for 10 consecutive days.During the stimulation, they underwent standardized speech and language therapy (SLT) simultaneously.
干预措施: temporal interference stimulation (Other)
sham stimulation
In the sham condition, TI was delivered only during the ramp-up and ramp-down periods (15 and 15 s); no current was delivered during the 30-minute intervention. Participants will receive sham TI once daily for 10 days. During the stimulation, they underwent standardized speech and language therapy (SLT) simultaneously.
干预措施: temporal interference stimulation (Other)
sham stimulation
In the sham condition, TI was delivered only during the ramp-up and ramp-down periods (15 and 15 s); no current was delivered during the 30-minute intervention. Participants will receive sham TI once daily for 10 days. During the stimulation, they underwent standardized speech and language therapy (SLT) simultaneously.
干预措施: speech and language therapy (Behavioral)
结局指标
主要结局
Aphasia Battery of Chinese (ABC,comprising spontaneous speech, auditory comprehension, repetition, naming, reading, writing, structural and spatial functions, application and calculation)
时间窗: Baseline;10 days; one-month follow-up
Language deficit was assessed by the same professional language therapist using the Aphasia Battery of Chinese (ABC). The multidimensional test contains four subtypes, including spontaneous speech (semi-standardized interview, assessment of the fluency, and information of speech; total score 20 points), auditory comprehension (yes or no question, auditory picture matching task, and verbal instruction; total score 230 points), repetition (words and sentences; total score 100 points), naming (simple objects, colors, pictures, and situations; total score 80 points), structural and spatial functions (draw the picture; total score 19 points), application (total score30 points), and calculation (total score20 points). The combined score is used to calculate an aphasia quotient (AQ) reflecting the overall severity of language impairment. Patients with AQ below 93.8 points were considered as aphasic.
Verbal fluency test (VFT)
时间窗: Baseline;10 days; one-month follow-up
The Verbal Fluency Test (VFT) is a cognitive assessment tool used to evaluate language production and executive function, where individuals generate words based on specific criteria within a one-minute timeframe. The total score reflects the number of acceptable words produced: for phonemic fluency, participants generate words starting with a specific letter, while for semantic fluency, they list words belonging to a designated category; scores typically range from 0 to 60, with higher scores indicating better verbal fluency and cognitive function.
Western Aphasia Battery (WAB, including fluency and information content)
时间窗: Baseline;10 days; one-month follow-up
The Western Aphasia Battery (WAB) is a comprehensive assessment tool designed to evaluate language abilities in individuals with aphasia, measuring various aspects of verbal communication, including fluency and information content. The total score for the WAB ranges from 0 to 100, with higher scores indicating better overall language function and less severe aphasia. Specifically, fluency assesses the ease and flow of speech, while information content evaluates the meaningfulness and relevance of the verbal output.
次要结局
- Language Assessment Manual (Including True Word Auditory Repetition, Picture Naming, Non-Word Auditory Repetition, Word Reading, Verb-Noun-Picture Matching, and Writing)(Baseline;10 days; one-month follow-up)
- Mini Mental State Examination (MMSE)(Baseline;10 days;one-month follow-up)
- Montreal Cognitive Assessment (MoCA)(Baseline;10 days; one-month follow-up)
- Brunnsrom stages of motor recovery(Baseline;10 days; one-month follow-up)
- Fugl-Meyer Assessment Scale (FMA)(Baseline;10 days; one-month follow-up)
- Hamilton Anxiety Rating Scale (HAMA)(Baseline;10 days; one-month follow-up)
- Hamilton Depression Rating Scale (HAMD)(Baseline;10 days; one-month follow-up)
- MRI measures(Baseline;10 days; one-month follow-up)
研究者
hupanpan
Department of Neurology, The First Affiliated Hospital of Anhui Medical University,Hefei,China
The First Affiliated Hospital of Anhui Medical University