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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03448133
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Anticipated Duration (Months): 46

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aphasia, Primary Progressive; Repetitive Transcranical Magnetic Stimulation	Device: Magstim rTMS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria
• Anticipated Study Start Date: Mar 1, 2018
• Anticipated Primary Completion Date: Oct 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; The device is made in London,UK
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; The device is made in London,UK

Outcome Measures

Primary Outcome Measures

1. Boston naming test evaluation [Baseline]

   Assessment of the language production

2. Boston naming test evaluation [One month(just after 20 times rTMS treatment)]

   Assessment of the language production

3. Western Aphasia Battery(WAB) Speech fluency [Baseline]

   Assessment of the language production

4. Western Aphasia Battery(WAB) Speech fluency [One month(just after 20 times rTMS treatment)]

   Assessment of the language production

5. Repetition Part of WAB [Baseline]

   Assessment of the repetition ability

6. Repetition Part of WAB [One month(just after 20 times rTMS treatment)]

   Assessment of the repetition ability

7. Word recognition Part of WAB [Baseline]

   Assessment of the reading

8. Word recognition Part of WAB [One month(just after 20 times rTMS treatment)]

   Assessment of the reading

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

   Assessment of the grammar ability

10. Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version) [One month(just after 20 times rTMS treatment)]

    Assessment of the grammar ability

Secondary Outcome Measures

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

   Graph theoretical analysis of the speech/language network

2. fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length) [One month(just after 20 times rTMS treatment)]

   Graph theoretical analysis of the speech/language network

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 75 Years
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT03448133
• Other Study ID Numbers: rTMSPPA-PUMCH
• First Posted: Feb 27, 2018
• Last Update Posted: Jun 5, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aphasia; Aphasia, Primary Progressive; Pick Disease of the Brain; Frontotemporal Dementia

Study Results

No Results Posted as of Jun 5, 2020