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WithdrawnNCT03448133Updated Jun 5, 2020

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

An interventional study of Magstim rTMS in Aphasia, Primary Progressive and Repetitive Transcranical Magnetic Stimulation, sponsored by Peking Union Medical College Hospital. Withdrawn. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-05.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Because of the expiration of the previous ethical approval documents
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Aphasia, Primary Progressive
  • Repetitive Transcranical Magnetic Stimulation
03

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceMagstim rTMS

    The device is made in London,UK

05

What researchers measure

Primary outcomes

  1. Boston naming test evaluation

    Assessment of the language production

    Time frame: Baseline

  2. Boston naming test evaluation

    Assessment of the language production

    Time frame: One month(just after 20 times rTMS treatment)

  3. Western Aphasia Battery(WAB) Speech fluency

    Assessment of the language production

    Time frame: Baseline

  4. Western Aphasia Battery(WAB) Speech fluency

    Assessment of the language production

    Time frame: One month(just after 20 times rTMS treatment)

  5. Repetition Part of WAB

    Assessment of the repetition ability

    Time frame: Baseline

  6. Repetition Part of WAB

    Assessment of the repetition ability

    Time frame: One month(just after 20 times rTMS treatment)

  7. Word recognition Part of WAB

    Assessment of the reading

    Time frame: Baseline

  8. Word recognition Part of WAB

    Assessment of the reading

    Time frame: One month(just after 20 times rTMS treatment)

  9. Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)

    Assessment of the grammar ability

    Time frame: Baseline

  10. Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)

    Assessment of the grammar ability

    Time frame: One month(just after 20 times rTMS treatment)

Secondary outcomes

  1. fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)

    Graph theoretical analysis of the speech/language network

    Time frame: Baseline

  2. fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)

    Graph theoretical analysis of the speech/language network

    Time frame: One month(just after 20 times rTMS treatment)

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Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03448133
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Feb 27, 2018
Start date
Mar 1, 2018 (estimated)
Primary completion
Oct 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Jun 5, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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