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

Aphasia, Primary Progressive Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03448133
• Other study ID #: rTMSPPA-PUMCH
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Pick Disease of the Brain
• Repetitive Transcranical Magnetic Stimulation

Intervention

Device:
• Magstim rTMS
The device is made in London,UK

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston naming test evaluation	Assessment of the language production	Baseline
Primary	Boston naming test evaluation	Assessment of the language production	One month(just after 20 times rTMS treatment)
Primary	Western Aphasia Battery(WAB) Speech fluency	Assessment of the language production	Baseline
Primary	Western Aphasia Battery(WAB) Speech fluency	Assessment of the language production	One month(just after 20 times rTMS treatment)
Primary	Repetition Part of WAB	Assessment of the repetition ability	Baseline
Primary	Repetition Part of WAB	Assessment of the repetition ability	One month(just after 20 times rTMS treatment)
Primary	Word recognition Part of WAB	Assessment of the reading	Baseline
Primary	Word recognition Part of WAB	Assessment of the reading	One month(just after 20 times rTMS treatment)
Primary	Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)	Assessment of the grammar ability	Baseline
Primary	Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)	Assessment of the grammar ability	One month(just after 20 times rTMS treatment)
Secondary	fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)	Graph theoretical analysis of the speech/language network	Baseline
Secondary	fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)	Graph theoretical analysis of the speech/language network	One month(just after 20 times rTMS treatment)