rTMS Treatment of Primary Progressive Aphasia

Primary Progressive Aphasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431401
• Other study ID #: PPA-rTMS
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 31, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia
• Repetitive Transcranical Magnetic Stimulation

Intervention

Device:
• Magstim rTMS
The device is made in London,UK

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	functional connectivity map (FC map)	Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.	1 day before the treatment
Secondary	functional connectivity map (FC map)	Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.	1 month, 3 months and 6 months after the treatment
Secondary	Standardized Uptake Value (SUV)	PET parameter to evaluate brain metabolism	1 day before the treatment
Secondary	Standardized Uptake Value (SUV)	PET parameter to evaluate brain metabolism	1 month, 3 months and 6 months after the treatment