Safety of combination therapy of HAL and repeptive trancranial magnetic stimulation

JRCT ID: jRCTs032220409

Registered date:25/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinsonian Disease
• Date of first enrollment: 25/10/2022
• Target sample size: 5
• Study type: Interventional

Intervention(s)

repeptive transcranial magnetic stimulation: 20 minutes once, 1 times a week,total 3 weeks
robot suit HAL: 60 minutes once, 3-4 times a week,total 3 weeks

Outcome(s)

Primary Outcome

frequency of adverse event
1) serious adverse event
2) Previously reported advers events in HAL (myalgia, contact dermatitis, abrasions, back pain, falls, contusions, limb pain, arthralgia)
3) Previously reported advers events in rTMS (scalp pain, irritation pain, facial discomfort, neck pain, stiff shoulders, headache, epilepsy, dizziness exacerbation)
4) Unexpected adverse event

Secondary Outcome

1.MDS- UPDRS 3rd score change
2. Freezing of gait questionnaire
3. Change in Timed up and go test
4. 10m change in walking time

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Patient who meet all of the following conditinons are targeted
1) Yahr classification: 2-4 Parkinson syndrome patients
2) Patients whose freezing gait do not improve even after using a sufficient amount of anti-Parkinson's disease drug
3)Patients aged over 20 under 80 at the time of informed consent
4)Patients who can consent to appropriate contraception for the duration of the study
5)Patients who have received sufficient explanation in participating in this study, and who have obtained written consent at their own free will with sufficient understanding.

Exclude criteria

patient who meet any of the following condition are not eligible
1) Patients who received a new start or increased dose of anti-PD drug within 12 weeks
2) Patients with other diseases such as occupied lesions on the head image
3) Cases in which rTMS is contraindicated in the guidelines on the safety of magnetic stimulation (2019 edition)
4)Patient who are considered difficult to train with HAL
5) Patients who are pregnant, may become pregnant, within 28 days after giving birth, or are breastfeeding
6) In addition, patients who are judged by the investigator or the investigator to be inappropriate for conducting this study safely.

Related Information

• Primary Sponsor: YAMANAKA Yoshitaka
• Source(s) of Monetary Support: Grant-in-Aid for Scientific Research(C),Clinical Research Initiation-Fund (of Chiba University Hospital)