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

NCT03448133 | Withdrawn

• 1 other identifier: rTMSPPA-PUMCH
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Aphasia, Primary Progressive; Repetitive Transcranical Magnetic Stimulation

Outcome Measures

Primary Outcomes (10)

• Boston naming test evaluation

  Assessment of the language production

  Baseline

• Boston naming test evaluation

  Assessment of the language production

  One month(just after 20 times rTMS treatment)

• Western Aphasia Battery(WAB) Speech fluency

  Assessment of the language production

  Baseline

• Western Aphasia Battery(WAB) Speech fluency

  Assessment of the language production

  One month(just after 20 times rTMS treatment)

• Repetition Part of WAB

  Assessment of the repetition ability

  Baseline

• Repetition Part of WAB

  Assessment of the repetition ability

  One month(just after 20 times rTMS treatment)

• Word recognition Part of WAB

  Assessment of the reading

  Baseline

• Word recognition Part of WAB

  Assessment of the reading

  One month(just after 20 times rTMS treatment)

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

  Assessment of the grammar ability

  Baseline

• 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 Outcomes (2)

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

  Baseline

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

  One month(just after 20 times rTMS treatment)

Study Arms (2)

rTMS treatment group

EXPERIMENTAL

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 treatment group

SHAM COMPARATOR

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

Magstim rTMS DEVICE

The device is made in London,UK

rTMS treatment group; sham treatment group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Aphasia, Primary Progressive

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 27, 2018
• Study Start: March 1, 2018
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 5, 2020

Record last verified: 2020-06