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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

Tracking Information
First Submitted Date  ICMJE February 10, 2018
First Posted Date  ICMJE February 27, 2018
Last Update Posted Date February 27, 2018
Estimated Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • Boston naming test evaluation [ Time Frame: Baseline ]
    Assessment of the language production
  • Boston naming test evaluation [ Time Frame: One month(just after 20 times rTMS treatment) ]
    Assessment of the language production
  • Western Aphasia Battery(WAB) Speech fluency [ Time Frame: Baseline ]
    Assessment of the language production
  • Western Aphasia Battery(WAB) Speech fluency [ Time Frame: One month(just after 20 times rTMS treatment) ]
    Assessment of the language production
  • Repetition Part of WAB [ Time Frame: Baseline ]
    Assessment of the repetition ability
  • Repetition Part of WAB [ Time Frame: One month(just after 20 times rTMS treatment) ]
    Assessment of the repetition ability
  • Word recognition Part of WAB [ Time Frame: Baseline ]
    Assessment of the reading
  • Word recognition Part of WAB [ Time Frame: One month(just after 20 times rTMS treatment) ]
    Assessment of the reading
  • Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version) [ Time Frame: Baseline ]
    Assessment of the grammar ability
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length) [ Time Frame: Baseline ]
    Graph theoretical analysis of the speech/language network
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE rTMS for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial
Official Title  ICMJE Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Aphasia, Primary Progressive
  • Repetitive Transcranical Magnetic Stimulation
Intervention  ICMJE Device: Magstim rTMS
The device is made in London,UK
Study Arms  ICMJE
  • 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
    Intervention: Device: Magstim rTMS
  • 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.
    Intervention: Device: Magstim rTMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yuzhou Guan, MD 8613910081750 guanyz001@163.com
Contact: Caiyan Liu, MD 8618601017840 liucy-pumch@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03448133
Other Study ID Numbers  ICMJE rTMSPPA-PUMCH
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking Union Medical College Hospital
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP