rTMS for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial

Study Overview
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Brief Summary
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The primary progressive aphasia (PPA) is a neurodegenerative condition characterized by a gradual, irreversible decline of language function (Mesulam, 2001). There are no known treatments for PPA so far. The relentless progression of PPA symptoms eventually leads to a profound impairment in communication ability and, ultimately, to more generalized deficits of cognition. Some cases and small studies reported that Transcranial Magnetic Stimulation (TMS), one of the non-invasive neuromodulation tech, can be employed to facilitate language production and improve the language ability in patients with PPA. Herein we will explore the tolerance and efficacy of TMS for the treatment of PPA by the randomized controlled trial .Meanwhile the functional MRI tech will be used to investigate the neural network changing in the procedure

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

Conditions
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Aphasia, Primary Progressive, 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: All participants had also been evaluated previously by a behavioral neurologist at the Peking Union Medical College Hospital and had been clinically diagnosed with a variant of PPA. Exclusion Criteria: Scored below 15 on the mini-mental state exam (MMSE) due to concerns that global cognitive impairment might preclude their ability to follow the directions and interfere with task performance. Had a history of seizures or unexplained loss of consciousness, pregnancy, surgical breach of the skull, or any other medical or surgical contraindication to receiving noninvasive brain stimulation. Is unable to complete the treatment and evaluations

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 devided into rTMS treatment and sham treatment by means of randomized methods.The protocol of 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 | Baseline | 
| Boston naming test evaluation | Assessment of the language production | One month(just after 20 times rTMS treatment) | 
| Western Aphasia Battery(WAB) Speech fluency | Assessment of the language production | Baseline | 
| Western Aphasia Battery(WAB) Speech fluency | Assessment of the language production | One month(just after 20 times rTMS treatment) | 
| Repetition Part of WAB | Assessment of the repetition ability | Baseline | 
| Repetition Part of WAB | Assessment of the repetition ability | One month(just after 20 times rTMS treatment) | 
| Word recognition Part of WAB | Assessment of the reading | Baseline | 
| Word recognition Part of WAB | Assessment of the reading | One month(just after 20 times rTMS treatment) | 
| Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version) | Assessment of the grammar ability | Baseline | 
| Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version) | Assessment of the grammar ability | One month(just after 20 times rTMS treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length) | Graph theoretical analysis of the speech/language network | Baseline | 
| fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length) | Graph theoretical analysis of the speech/language network | One month(just after 20 times rTMS treatment) |