Double blinded study of high frequency repetitive transcranial magnetic stimulator for Parkinson's disease.
- Conditions
- Parkinson's disease patients
- Registration Number
- JPRN-jRCT2092220299
- Lead Sponsor
- ihon Kohden Corporation
- Brief Summary
The safety of the rTMS treatment for Parkinson's disease has been confirmed. However, the efficacy of the rTMS treatment for motor symptoms and non-motor symptoms was not proven in this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Eligible patients are expected to meet all of the following criteria:
(1) PD patients diagnosed as Idiopathic PD based on the criteria of UK Parkinson's Disease Society brain bank
(2) PD patients whose symptoms are not considerably improved with L-dopa and/or dopamine agonist treatments, and also are at stage 2 to 4 in the modified Hoehn-Yahr Scale
(3) Patients who have been receiving a stable dosage of L-dopa and/or dopamine agonist at regular intervals for 4 weeks before rTMS treatment
(4) Patients who have been receiving a stable dosage of anticholinergic drugs, selegiline, entacapone, amantadine hydrochloride, droxidopa, zonisamide or istradefylline at regular intervals for 4 weeks before rTMS treatment
(5) Patients 20 years and older at time of providing informed consent
(6) In-patients or out-patients who can come to the hospitals where the study is conducted
(7) Patients who have voluntarily provided written consent for participation in this study, based on complete understanding our full explanation
Patients meeting any of the following criteria are ineligible for this study:
(1) Patients exhibiting severe psychiatric symptoms such as severe hallucinations, delusion, confusion, abnormal behavior and so on, within 6 months (26 weeks) before the initiation of rTMS treatment
(2) Patients with drug or alcohol addiction (by ICD10 classification)
(3) Patients with less than a 24 score in mini-mental state examination at a screening
(4) Patients with less than a 11 score in UPDRS Part III at a screening
(5) Patients having a history of receiving surgical treatments (such as deep brain stimulation)
(6) Patients having taken medication listed below within 4 weeks of the initiation of rTMS treatment
+ dopamine receptor antagonistic antipsychotics (e.g. phenothiazines, butyrophenones, benzamides)
+ dopamine receptor antagonistic cardiovascular drugs (e.g. reserpine)
(7) Patients taking medication listed below currently or having taken it within 1 week of the initiation of rTMS treatment.
+ dopamine receptor antagonistic gastrointestinal drugs (e.g. metoclopramide and sulpiride, except for domperidone)
(8) Patients who have previously received rTMS treatment
(9) Patients with metal implants (e.g. clips, metals, and cochlear implant) in the head (except for oral implants)
(10) Patients having a cardiac pacemaker, implantable cardioverter defibrillators (ICD), vagal nerve stimulator or implantable drug infusion pump
(11) Patients with a large cerebral infarction, cerebral trauma, brain tumor, or epilepsy
(12) Patients having a malignant tumor, severe hepatic, renal, hematologic, respiratory, gastrointestinal or cardiovascular disease or metabolic or electrolyte imbalance. (Patients having a history of malignant tumors but being free of relapse for more than 5 years are allowed to be included. Severity criteria are based on grade 4 in Common Terminology Criteria for Adverse Events (CTCAE) v4.0.)
(13) Patients in whom no motor evoked potentials were elicited from the tibialis anterior muscle by TMS at the maximum stimulator output
(14) Patients who participated in other trials within 12 weeks before the date of providing informed consent for this study
(15) Pregnant patients or patients having a possibility of pregnancy. Patients who are breast feeding or attempting to become pregnant.
(16) Patients who were judged as ineligible by the principle investigator or subinvestigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in UPDRS Part III (motor symptoms) total score at drug-on stage from the baseline score.
- Secondary Outcome Measures
Name Time Method 1) Time course of modified Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Part I to IV, total)<br>2) Time course of self-assessed daily activity (Visual analog scale)<br>3) Time course of averaged duration of off period in a day<br>4) Changes in dropouts due to increasing or addition of anti-Parkinsonian drugs as a result of worsening of motor symptoms.