Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in People With Parkinson's Disease
-
- STATUS
- Recruiting
-
- days left to enroll
- 54
-
- participants needed
- 30
-
- sponsor
- Taipei Medical University Shuang Ho Hospital
Summary
Parkinson's disease (PD) is the second most common neurodegenerative disease. The cardinal symptoms of PD are tremor, rigidity, bradykinesia and postural instability. Gait disturbance is also one of the key features of PD. At present, the mainstream treatment of PD is the dopaminergic supplement. However, the response to the medical treatment varies between symptoms. Rigidity and bradykinesia respond to the medical treatment the best, and tremor respond partially. Gait disorders do not usually respond to the dopaminergic medication. Freezing of gait (FOG) is one of the most notorious and devastating presentation of gait disorders in PD. Currently, there is no available treatment for FOG, even the invasive deep brain stimulation does not work on it. Repetitive transcortical magnetic stimulation (rTMS) is a novel non-invasive intervention. Through the magnetic stimulation, brain neurons could be activated by the electrical current. The application of rTMS had been approved by US FDA for the treatment of depression. The possible effect of rTMS may result from the stimulation-related neuronal plasticity. Regarding PD, rTMS also had been found to had some effect on different motor symptoms, mainly on the bradykinesia and rigidity but not gait. The present study would like to test the accumulative effect of rTMS on gait disorders of PD, especially the phenomenon of FOG. All the study subjects will receive rTMS under intermittent theta burst stimulation (iTBS) mode at supplementary motor area (SMA). Gait analysis and other motor performance will be assessed before and after the intervention.
Description
The present trial is designed as an open-label, uncontrolled pilot study for evaluating the effect of rTMS on improvement of freezing of gait (FOG) in people with PD. The primary endpoint is the improvement of FOG, and the secondary endpoint is the improvement of motor symptoms and cognition. All participants need to complete the informed consent before they are enrolled into the trial. Demographic data includes age, sex, medical history, drug history, disease duration, modified Hoehn-Yahr stage, and UPDRS score are collected. Gait function are evaluated with time up and go (TUG), freezing of gait questionnaire (FOG-Q), and Gait-up device analysis before trial starting. Cognitive function including mini-mental state examination (MMSE), clocking drawing test, Wechsler memory scale (WMS)-world list test and spatial span test, trial making test A and B, category fluency test (animal naming), and beck depression inventory-II are tested by trained neuropsychiatrists. Pre-treatment brain image examined by magnetic resonance image (MRI) and blood sampling for synapse protein level are performed. The participants are then arranged to receive theta burst stimulation for 5 days by Magstim Rapid system (Super Rapid 2) equipped with air cooled coil (D70), stimulating on supplementary motor area (SMA). After the intervention, post-treatment evaluation including gait function, motor symptoms, cognition, brain MRI, and blood sampling will be performed again with the same methods at 1 month later. Any adverse event during the trial period will also be recorded. The trial is expected to be conducted in Shuang-Ho hospital, Taipei Medical University.
Details
| Condition | Spastic gait |
|---|---|
| Treatment | Theta bust stimulating |
| Clinical Study Identifier | NCT04695496 |
| Sponsor | Taipei Medical University Shuang Ho Hospital |
| Last Modified on | 11 April 2021 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer