rTMS Treatment of Primary Progressive Aphasia
- Conditions
- Repetitive Transcranical Magnetic StimulationPrimary Progressive Aphasia
- Interventions
- Device: Magstim rTMS
- Registration Number
- NCT04431401
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
Primary Progressive Aphasia (PPA) is a neurodegenerative disease in which language function is gradually and progressively impaired. Patients will eventually be disabled in communication and have cognition deficits, which put a heavy burden not only on their families but also on the whole society. However, no effective treatment for PPA has been explored so far. The current clinical randomized trial is to study the safety and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of PPA. Also, multi-modality of neuroimaging techniques, such as functional MRI and PET will be used to investigate brain network changing in this procedure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Clinical diagnosis of PPA
- Scored below 15 on the mini-mental state exam (MMSE)
- history of seizures or unexplained loss of consciousness
- pregnancy
- surgical breach of the skull
- MRI contraindication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham treatment group Magstim rTMS The control group is to receive sham treatment. The device is the same as the one used in the real treatment group. rTMS treatment group Magstim rTMS The participants will be divided into the rTMS treatment group and the sham treatment group by means of randomized methods.The protocol of the treatment is to use rTMS with high frequency 10/20Hz 120%RMT 20 times for one month. The device is Magtism rTMS made in London, UK
- Primary Outcome Measures
Name Time Method Western Aphasia Battery (WAB) Word recognition 1 month, 3 months and 6 months after the treatment Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
Boston naming test evaluation 1 month, 3 months and 6 months after the treatment Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
Western Aphasia Battery (WAB) Repetition 1 month, 3 months and 6 months after the treatment Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
Western Aphasia Battery (WAB) Speech fluency 1 month, 3 months and 6 months after the treatment Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version) 1 month, 3 months and 6 months after the treatment Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.
- Secondary Outcome Measures
Name Time Method functional connectivity map (FC map) 1 month, 3 months and 6 months after the treatment Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.
Standardized Uptake Value (SUV) 1 month, 3 months and 6 months after the treatment PET parameter to evaluate brain metabolism
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China