Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
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
Intervention: Magstim rTMS (Device)
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.
Intervention: Magstim rTMS (Device)
Outcomes
Primary Outcomes
Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
Time Frame: One month(just after 20 times rTMS treatment)
Assessment of the grammar ability
Boston naming test evaluation
Time Frame: One month(just after 20 times rTMS treatment)
Assessment of the language production
Western Aphasia Battery(WAB) Speech fluency
Time Frame: One month(just after 20 times rTMS treatment)
Assessment of the language production
Repetition Part of WAB
Time Frame: One month(just after 20 times rTMS treatment)
Assessment of the repetition ability
Word recognition Part of WAB
Time Frame: One month(just after 20 times rTMS treatment)
Assessment of the reading
Boston naming test evaluation
Time Frame: Baseline
Assessment of the language production
Western Aphasia Battery(WAB) Speech fluency
Time Frame: Baseline
Assessment of the language production
Repetition Part of WAB
Time Frame: Baseline
Assessment of the repetition ability
Word recognition Part of WAB
Time Frame: Baseline
Assessment of the reading
Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
Time Frame: Baseline
Assessment of the grammar ability
Secondary Outcomes
- fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)(One month(just after 20 times rTMS treatment))
- fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)(Baseline)