Clinical trial NCT03448133: rTMS for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial
Official title: Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aphasia, Primary Progressive
Repetitive Transcranical Magnetic Stimulation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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:

1. 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.
2. 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.
3. Is unable to complete the treatment and evaluations

Primary outcomes:
measure: Boston naming test evaluation
timeFrame: Baseline
measure: Boston naming test evaluation
timeFrame: One month(just after 20 times rTMS treatment)
measure: Western Aphasia Battery(WAB) Speech fluency
timeFrame: Baseline
measure: Western Aphasia Battery(WAB) Speech fluency
timeFrame: One month(just after 20 times rTMS treatment)
measure: Repetition Part of WAB
timeFrame: Baseline
measure: Repetition Part of WAB
timeFrame: One month(just after 20 times rTMS treatment)
measure: Word recognition Part of WAB
timeFrame: Baseline
measure: Word recognition Part of WAB
timeFrame: One month(just after 20 times rTMS treatment)
measure: Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
timeFrame: Baseline
measure: Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
timeFrame: One month(just after 20 times rTMS treatment)
Secondary outcomes:
measure: fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)
timeFrame: Baseline
measure: fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)
timeFrame: One month(just after 20 times rTMS treatment)
Other outcomes:
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