Safety of combination therapy of HAL and repeptive trancranial magnetic stimulatio

Phase 1

Recruiting

• Conditions: Parkinsonian Disease; freezing gait; D010300

• Registration Number: JPRN-jRCTs032220409
• Lead Sponsor: YAMANAKA Yoshitaka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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