Clinical Study on the Safety and Efficacy of Temporal Interference Stimulation in the Treatment of Post-Stroke Aphasia

NCT07346378 | Recruiting

• 1 other identifier: AHMU-TI-PSA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-stroke Aphasia

Outcome Measures

Primary Outcomes (3)

• Aphasia Battery of Chinese (ABC,comprising spontaneous speech, auditory comprehension, repetition, naming, reading, writing, structural and spatial functions, application and calculation)

  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.

  Baseline;10 days; one-month follow-up

• Verbal fluency test (VFT)

  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.

  Baseline;10 days; one-month follow-up

• Western Aphasia Battery (WAB, including fluency and information content)

  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.

  Baseline;10 days; one-month follow-up

Secondary Outcomes (8)

• 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

Study Arms (2)

real stimulation

ACTIVE COMPARATOR

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.

Other: temporal interference stimulation; Behavioral: speech and language therapy

sham stimulation

SHAM COMPARATOR

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.

Other: temporal interference stimulation; Behavioral: speech and language therapy

Interventions

temporal interference stimulation OTHER

The envelope frequency of the TIS employed is set at 30 Hz, while the current frequencies are planned to be 1400 Hz and 1430 Hz. Due to individual variability in sensitivity to TIS, we intend to make necessary adjustments to the stimulation frequency or duration during the treatment process. For the continuous stimulation mode of TIS, the protocol follows the post-operative control consensus from Chinese experts in deep brain stimulation for neurological disorders. Electrode placement adheres to the international 10-10 EEG electrode system, with stimulation parameters (electrode positions and current parameters) determined based on the TIS optimization method proposed by the project team. The constraints are as follows: the total current across all electrodes must be less than 10 mA, and the maximum current for any single electrode is limited to 2.5 mA. The ramp-up time for stimulation is set at 30 seconds. The stimulation target for this project is based on MRI localization.

real stimulation; sham stimulation

speech and language therapy BEHAVIORAL

Speech and Language Therapy (SLT) was conducted by a certified Speech-Language Pathologist (SLP), providing standardized language rehabilitation for 40 minutes daily, which included 30 minutes of SLT synchronized with TI. Based on the results of the patients' language assessments, the SLP developed and implemented an individualized rehabilitation treatment plan. The primary rehabilitation methodologies included articulation exercises, phoneme stimulation, Schuell stimulation therapy, melodic intonation therapy, object naming exercises, word reading practice, and situational conversation practice.

real stimulation; sham stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Interventions

Speech Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

Yuqian Zhan

CONTACT

+86 133 3564 4731; zhanyuqian1998@163.com

Tongjian Bai

CONTACT

+8615256972606; baiyunong1990@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurology, The First Affiliated Hospital of Anhui Medical University,Hefei,China

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 16, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)