rTMS Treatment of Primary Progressive Aphasia

Study Overview
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Brief Summary
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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.

Official Title
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Repetitive Transcranial Magnetic Stimulation in the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial

Conditions
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Primary Progressive Aphasia, Repetitive Transcranical Magnetic Stimulation

Intervention / Treatment
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* Device: Magstim rTMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS treatment group<br>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 | Device: Magstim rTMS<br>* The device is made in London,UK<br>|
| Sham Comparator: sham treatment group<br>The control group is to receive sham treatment. The device is the same as the one used in the real treatment group. | Device: Magstim rTMS<br>* The device is made in London,UK<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston naming test evaluation | Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome. | 1 day before the treatment | 
| Boston naming test evaluation | Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome. | 1 month, 3 months and 6 months after the treatment | 
| Western Aphasia Battery (WAB) Speech fluency | Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome. | 1 day before the treatment | 
| Western Aphasia Battery (WAB) Speech fluency | Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome. | 1 month, 3 months and 6 months after the treatment | 
| Western Aphasia Battery (WAB) Repetition | Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome. | 1 day before the treatment | 
| Western Aphasia Battery (WAB) Repetition | Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome. | 1 month, 3 months and 6 months after the treatment | 
| Western Aphasia Battery (WAB) Word recognition | Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome. | 1 day before the treatment | 
| Western Aphasia Battery (WAB) Word recognition | Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome. | 1 month, 3 months and 6 months after the treatment | 
| Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version) | Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome. | 1 day before the treatment | 
| Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version) | Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome. | 1 month, 3 months and 6 months after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional connectivity map (FC map) | 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. | 1 day before the treatment | 
| functional connectivity map (FC map) | 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. | 1 month, 3 months and 6 months after the treatment | 
| Standardized Uptake Value (SUV) | PET parameter to evaluate brain metabolism | 1 day before the treatment | 
| Standardized Uptake Value (SUV) | PET parameter to evaluate brain metabolism | 1 month, 3 months and 6 months after the treatment |