Primary Progressive Aphasia, Repetitive Transcranical Magnetic Stimulation
Conditions
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.
Interventions
DEVICEMagstim rTMS
The device is made in London,UK
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of PPA
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Aphasia Battery (WAB) Speech fluency | 1 day before the treatment | Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome. |
| Western Aphasia Battery (WAB) Word recognition | 1 day before the treatment | Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome. |
| Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version) | 1 day before the treatment | Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome. |
| Boston naming test evaluation | 1 day before the treatment | Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome. |
| Western Aphasia Battery (WAB) Repetition | 1 day before the treatment | Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Uptake Value (SUV) | 1 day before the treatment | PET parameter to evaluate brain metabolism |
| functional connectivity map (FC map) | 1 day before 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. |
Countries
China
Outcome results
None listed