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rTMS for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial

Primary Purpose

Aphasia, Primary Progressive, Repetitive Transcranical Magnetic Stimulation

Status
Withdrawn
Phase
Not Applicable
Locations
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 Aphasia, Primary Progressive

Eligibility Criteria

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

Inclusion Criteria:

All participants had also been evaluated previously by a behavioral neurologist at the Peking Union Medical College Hospital and had been clinically diagnosed with a variant of PPA.

Exclusion Criteria:

  1. Scored below 15 on the mini-mental state exam (MMSE) due to concerns that global cognitive impairment might preclude their ability to follow the directions and interfere with task performance.
  2. Had a history of seizures or unexplained loss of consciousness, pregnancy, surgical breach of the skull, or any other medical or surgical contraindication to receiving noninvasive brain stimulation.
  3. Is unable to complete the treatment and evaluations

Sites / Locations

    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 devided into rTMS treatment and sham treatment by means of randomized methods.The protocol of 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
    Boston naming test evaluation
    Assessment of the language production
    Western Aphasia Battery(WAB) Speech fluency
    Assessment of the language production
    Western Aphasia Battery(WAB) Speech fluency
    Assessment of the language production
    Repetition Part of WAB
    Assessment of the repetition ability
    Repetition Part of WAB
    Assessment of the repetition ability
    Word recognition Part of WAB
    Assessment of the reading
    Word recognition Part of WAB
    Assessment of the reading
    Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
    Assessment of the grammar ability
    Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
    Assessment of the grammar ability

    Secondary Outcome Measures

    fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)
    Graph theoretical analysis of the speech/language network
    fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)
    Graph theoretical analysis of the speech/language network

    Full Information

    First Posted
    February 10, 2018
    Last Updated
    June 3, 2020
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03448133
    Brief Title
    rTMS for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial
    Official Title
    Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Because of the expiration of the previous ethical approval documents
    Study Start Date
    March 1, 2018 (Anticipated)
    Primary Completion Date
    October 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (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
    The primary progressive aphasia (PPA) is a neurodegenerative condition characterized by a gradual, irreversible decline of language function (Mesulam, 2001). There are no known treatments for PPA so far. The relentless progression of PPA symptoms eventually leads to a profound impairment in communication ability and, ultimately, to more generalized deficits of cognition. Some cases and small studies reported that Transcranial Magnetic Stimulation (TMS), one of the non-invasive neuromodulation tech, can be employed to facilitate language production and improve the language ability in patients with PPA. Herein we will explore the tolerance and efficacy of TMS for the treatment of PPA by the randomized controlled trial .Meanwhile the functional MRI tech will be used to investigate the neural network changing in the procedure

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aphasia, Primary Progressive, 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
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    rTMS treatment group
    Arm Type
    Experimental
    Arm Description
    The participants will be devided into rTMS treatment and sham treatment by means of randomized methods.The protocol of 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
    Time Frame
    Baseline
    Title
    Boston naming test evaluation
    Description
    Assessment of the language production
    Time Frame
    One month(just after 20 times rTMS treatment)
    Title
    Western Aphasia Battery(WAB) Speech fluency
    Description
    Assessment of the language production
    Time Frame
    Baseline
    Title
    Western Aphasia Battery(WAB) Speech fluency
    Description
    Assessment of the language production
    Time Frame
    One month(just after 20 times rTMS treatment)
    Title
    Repetition Part of WAB
    Description
    Assessment of the repetition ability
    Time Frame
    Baseline
    Title
    Repetition Part of WAB
    Description
    Assessment of the repetition ability
    Time Frame
    One month(just after 20 times rTMS treatment)
    Title
    Word recognition Part of WAB
    Description
    Assessment of the reading
    Time Frame
    Baseline
    Title
    Word recognition Part of WAB
    Description
    Assessment of the reading
    Time Frame
    One month(just after 20 times rTMS treatment)
    Title
    Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
    Description
    Assessment of the grammar ability
    Time Frame
    Baseline
    Title
    Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
    Description
    Assessment of the grammar ability
    Time Frame
    One month(just after 20 times rTMS treatment)
    Secondary Outcome Measure Information:
    Title
    fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)
    Description
    Graph theoretical analysis of the speech/language network
    Time Frame
    Baseline
    Title
    fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)
    Description
    Graph theoretical analysis of the speech/language network
    Time Frame
    One month(just after 20 times rTMS 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: All participants had also been evaluated previously by a behavioral neurologist at the Peking Union Medical College Hospital and had been clinically diagnosed with a variant of PPA. Exclusion Criteria: Scored below 15 on the mini-mental state exam (MMSE) due to concerns that global cognitive impairment might preclude their ability to follow the directions and interfere with task performance. Had a history of seizures or unexplained loss of consciousness, pregnancy, surgical breach of the skull, or any other medical or surgical contraindication to receiving noninvasive brain stimulation. Is unable to complete the treatment and evaluations

    12. IPD Sharing Statement

    Learn more about this trial

    rTMS for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial

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