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Completed

NCT Number: NCT04431401

rTMS Treatment of Primary Progressive Aphasia

Primary Progressive Aphasia (PPA) is a neurodegenerative disease in which language function is gradually and progressively impaired. Patients will eventually be disabled in communication and have cognition deficits, which put a heavy burden not only on their families but also on the whole society. However, no effective treatment for PPA has been explored so far. The current clinical randomized trial is to study the safety and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of PPA. Also, multi-modality of neuroimaging techniques, such as functional MRI and PET will be used to investigate brain network changing in this procedure.

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Key information

Conditions

Primary Progressive Aphasia Aphasia Aphasia, Primary Progressive Brain Diseases Central Nervous System Diseases Communication Disorders Dementia Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Repetitive Transcranical Magnetic Stimulation Signs and Symptoms Speech Disorders

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of PPA

Exclusion criteria

  • Scored below 15 on the mini-mental state exam (MMSE)
  • history of seizures or unexplained loss of consciousness
  • pregnancy
  • surgical breach of the skull
  • MRI contraindication

Treatment and study plan

Magstim rTMS

Device

The device is made in London,UK

Primary outcomes

  1. Boston naming test evaluation

    Time frame: 1 day before the treatment

    Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.

  2. Boston naming test evaluation

    Time frame: 1 month, 3 months and 6 months after the treatment

    Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.

  3. Western Aphasia Battery (WAB) Speech fluency

    Time frame: 1 day before the treatment

    Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.

  4. Western Aphasia Battery (WAB) Speech fluency

    Time frame: 1 month, 3 months and 6 months after the treatment

    Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.

  5. Western Aphasia Battery (WAB) Repetition

    Time frame: 1 day before the treatment

    Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.

  6. Western Aphasia Battery (WAB) Repetition

    Time frame: 1 month, 3 months and 6 months after the treatment

    Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.

  7. Western Aphasia Battery (WAB) Word recognition

    Time frame: 1 day before the treatment

    Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.

  8. Western Aphasia Battery (WAB) Word recognition

    Time frame: 1 month, 3 months and 6 months after the treatment

    Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.

  9. Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)

    Time frame: 1 day before the treatment

    Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.

  10. Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)

    Time frame: 1 month, 3 months and 6 months after the treatment

    Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.

Secondary outcomes

  1. functional connectivity map (FC map)

    Time frame: 1 day before the treatment

    Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.

  2. functional connectivity map (FC map)

    Time frame: 1 month, 3 months and 6 months after the treatment

    Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.

  3. Standardized Uptake Value (SUV)

    Time frame: 1 day before the treatment

    PET parameter to evaluate brain metabolism

  4. Standardized Uptake Value (SUV)

    Time frame: 1 month, 3 months and 6 months after the treatment

    PET parameter to evaluate brain metabolism

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Repetitive Transcranial Magnetic Stimulation in the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2020
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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