rTMS Treatment of Primary Progressive Aphasia
Repetitive Transcranial Magnetic Stimulation in the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedJanuary 12, 2024
March 1, 2023
2 years
June 3, 2020
January 10, 2024
Conditions
Outcome Measures
Primary Outcomes (10)
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 Outcomes (4)
functional connectivity map (FC map)
1 day before the treatment
functional connectivity map (FC map)
1 month, 3 months and 6 months after the treatment
Standardized Uptake Value (SUV)
1 day before the treatment
Standardized Uptake Value (SUV)
1 month, 3 months and 6 months after the treatment
Study Arms (2)
rTMS treatment group
EXPERIMENTALThe 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
sham treatment group
SHAM COMPARATORThe control group is to receive sham treatment. The device is the same as the one used in the real treatment group.
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of PPA
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
Huang Y, Tan Y, Hao H, Li J, Liu C, Hu Y, Wu Y, Ding Q, Zhou Y, Li Y, Guan Y. Treatment of primary progressive aphasia by repetitive transcranial magnetic stimulation: a randomized, double-blind, placebo-controlled study. J Neural Transm (Vienna). 2023 Feb;130(2):111-123. doi: 10.1007/s00702-023-02594-w. Epub 2023 Jan 20.
PMID: 36662282DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 16, 2020
Study Start
July 1, 2020
Primary Completion
July 1, 2022
Study Completion
August 31, 2022
Last Updated
January 12, 2024
Record last verified: 2023-03