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

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ClinicalTrials.gov Identifier: NCT03448133
Recruitment Status : Not yet recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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

Condition or disease Intervention/treatment Phase
Aphasia, Primary Progressive Repetitive Transcranical Magnetic Stimulation Device: Magstim rTMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: rTMS treatment group
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
Device: Magstim rTMS
The device is made in London,UK

Sham Comparator: 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.
Device: Magstim rTMS
The device is made in London,UK




Primary Outcome Measures :
  1. Boston naming test evaluation [ Time Frame: Baseline ]
    Assessment of the language production

  2. Boston naming test evaluation [ Time Frame: One month(just after 20 times rTMS treatment) ]
    Assessment of the language production

  3. Western Aphasia Battery(WAB) Speech fluency [ Time Frame: Baseline ]
    Assessment of the language production

  4. Western Aphasia Battery(WAB) Speech fluency [ Time Frame: One month(just after 20 times rTMS treatment) ]
    Assessment of the language production

  5. Repetition Part of WAB [ Time Frame: Baseline ]
    Assessment of the repetition ability

  6. Repetition Part of WAB [ Time Frame: One month(just after 20 times rTMS treatment) ]
    Assessment of the repetition ability

  7. Word recognition Part of WAB [ Time Frame: Baseline ]
    Assessment of the reading

  8. Word recognition Part of WAB [ Time Frame: One month(just after 20 times rTMS treatment) ]
    Assessment of the reading

  9. Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version) [ Time Frame: Baseline ]
    Assessment of the grammar ability

  10. Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version) [ Time Frame: One month(just after 20 times rTMS treatment) ]
    Assessment of the grammar ability


Secondary Outcome Measures :
  1. fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length) [ Time Frame: Baseline ]
    Graph theoretical analysis of the speech/language network

  2. fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length) [ Time Frame: One month(just after 20 times rTMS treatment) ]
    Graph theoretical analysis of the speech/language network



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448133


Contacts
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Contact: Yuzhou Guan, MD 8613910081750 guanyz001@163.com
Contact: Caiyan Liu, MD 8618601017840 liucy-pumch@163.com

Sponsors and Collaborators
Peking Union Medical College Hospital

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03448133     History of Changes
Other Study ID Numbers: rTMSPPA-PUMCH
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

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

Additional relevant MeSH terms:
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Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases