Clinical trial NCT04431401: rTMS Treatment of Primary Progressive Aphasia
Official title: Repetitive Transcranial Magnetic Stimulation in the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Progressive Aphasia
Repetitive Transcranical Magnetic Stimulation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 40
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Boston naming test evaluation
timeFrame: 1 day before the treatment
measure: Boston naming test evaluation
timeFrame: 1 month, 3 months and 6 months after the treatment
measure: Western Aphasia Battery (WAB) Speech fluency
timeFrame: 1 day before the treatment
measure: Western Aphasia Battery (WAB) Speech fluency
timeFrame: 1 month, 3 months and 6 months after the treatment
measure: Western Aphasia Battery (WAB) Repetition
timeFrame: 1 day before the treatment
measure: Western Aphasia Battery (WAB) Repetition
timeFrame: 1 month, 3 months and 6 months after the treatment
measure: Western Aphasia Battery (WAB) Word recognition
timeFrame: 1 day before the treatment
measure: Western Aphasia Battery (WAB) Word recognition
timeFrame: 1 month, 3 months and 6 months after the treatment
measure: Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
timeFrame: 1 day before the treatment
measure: Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
timeFrame: 1 month, 3 months and 6 months after the treatment
Secondary outcomes:
measure: functional connectivity map (FC map)
timeFrame: 1 day before the treatment
measure: functional connectivity map (FC map)
timeFrame: 1 month, 3 months and 6 months after the treatment
measure: Standardized Uptake Value (SUV)
timeFrame: 1 day before the treatment
measure: Standardized Uptake Value (SUV)
timeFrame: 1 month, 3 months and 6 months after the treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: