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Clinical Trials/NCT04431401
NCT04431401
Completed
Not Applicable

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

Peking Union Medical College Hospital1 site in 1 country40 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Progressive Aphasia
Sponsor
Peking Union Medical College Hospital
Enrollment
40
Locations
1
Primary Endpoint
Western Aphasia Battery (WAB) Word recognition
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
August 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Western Aphasia Battery (WAB) Word recognition

Time Frame: 1 month, 3 months and 6 months after the treatment

Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.

Boston naming test evaluation

Time Frame: 1 month, 3 months and 6 months after the treatment

Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.

Western Aphasia Battery (WAB) Repetition

Time Frame: 1 month, 3 months and 6 months after the treatment

Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.

Western Aphasia Battery (WAB) Speech fluency

Time Frame: 1 month, 3 months and 6 months after the treatment

Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.

Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)

Time Frame: 1 month, 3 months and 6 months after the treatment

Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.

Secondary Outcomes

  • functional connectivity map (FC map)(1 month, 3 months and 6 months after the treatment)
  • Standardized Uptake Value (SUV)(1 month, 3 months and 6 months after the treatment)

Study Sites (1)

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