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rTMS Treatment of Primary Progressive Aphasia

Primary Purpose

Primary Progressive Aphasia, Repetitive Transcranical Magnetic Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magstim rTMS
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Progressive Aphasia

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

rTMS treatment group

sham treatment group

Arm Description

The 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

The control group is to receive sham treatment. The device is the same as the one used in the real treatment group.

Outcomes

Primary Outcome Measures

Boston naming test evaluation
Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
Boston naming test evaluation
Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
Western Aphasia Battery (WAB) Speech fluency
Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
Western Aphasia Battery (WAB) Speech fluency
Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
Western Aphasia Battery (WAB) Repetition
Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
Western Aphasia Battery (WAB) Repetition
Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
Western Aphasia Battery (WAB) Word recognition
Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
Western Aphasia Battery (WAB) Word recognition
Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
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.
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.

Secondary Outcome Measures

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.
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.
Standardized Uptake Value (SUV)
PET parameter to evaluate brain metabolism
Standardized Uptake Value (SUV)
PET parameter to evaluate brain metabolism

Full Information

First Posted
June 3, 2020
Last Updated
July 31, 2022
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04431401
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Progressive Aphasia, Repetitive Transcranical Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rTMS treatment group
Arm Type
Experimental
Arm Description
The 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
Arm Title
sham treatment group
Arm Type
Sham Comparator
Arm Description
The control group is to receive sham treatment. The device is the same as the one used in the real treatment group.
Intervention Type
Device
Intervention Name(s)
Magstim rTMS
Intervention Description
The device is made in London,UK
Primary Outcome Measure Information:
Title
Boston naming test evaluation
Description
Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
Time Frame
1 day before the treatment
Title
Boston naming test evaluation
Description
Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
Time Frame
1 month, 3 months and 6 months after the treatment
Title
Western Aphasia Battery (WAB) Speech fluency
Description
Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
Time Frame
1 day before the treatment
Title
Western Aphasia Battery (WAB) Speech fluency
Description
Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
Time Frame
1 month, 3 months and 6 months after the treatment
Title
Western Aphasia Battery (WAB) Repetition
Description
Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
Time Frame
1 day before the treatment
Title
Western Aphasia Battery (WAB) Repetition
Description
Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
Time Frame
1 month, 3 months and 6 months after the treatment
Title
Western Aphasia Battery (WAB) Word recognition
Description
Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
Time Frame
1 day before the treatment
Title
Western Aphasia Battery (WAB) Word recognition
Description
Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
Time Frame
1 month, 3 months and 6 months after the treatment
Title
Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
Description
Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.
Time Frame
1 day before the treatment
Title
Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
Description
Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.
Time Frame
1 month, 3 months and 6 months after the treatment
Secondary Outcome Measure Information:
Title
functional connectivity map (FC map)
Description
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.
Time Frame
1 day before the treatment
Title
functional connectivity map (FC map)
Description
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.
Time Frame
1 month, 3 months and 6 months after the treatment
Title
Standardized Uptake Value (SUV)
Description
PET parameter to evaluate brain metabolism
Time Frame
1 day before the treatment
Title
Standardized Uptake Value (SUV)
Description
PET parameter to evaluate brain metabolism
Time Frame
1 month, 3 months and 6 months after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuzhou Guan
Phone
8613910081750
Email
guanyz001@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Caiyan Liu
Phone
8618601017840
Email
liucy-pumch@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuzhou Guan
Phone
8613910081750

12. IPD Sharing Statement

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rTMS Treatment of Primary Progressive Aphasia

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