rTMS Treatment of Primary Progressive Aphasia

NCT ID: NCT04431401

Last Updated: 2024-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Progressive Aphasia Repetitive Transcranical Magnetic Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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rTMS treatment group

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

Group Type EXPERIMENTAL

Magstim rTMS

Intervention Type DEVICE

The device is made in London,UK

sham treatment group

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

Group Type SHAM_COMPARATOR

Magstim rTMS

Intervention Type DEVICE

The device is made in London,UK

Interventions

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Magstim rTMS

The device is made in London,UK

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36662282 (View on PubMed)

Other Identifiers

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PPA-rTMS

Identifier Type: -

Identifier Source: org_study_id

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