A randomized, double-blind, placebo- controlled, multi-center, parallel study concerning the efficacy of repetitive transcranial magnetic stimulation over the supplementary motor area in treatment of motor and non- motor symptoms in Parkinson's disease

UMIN ID: UMIN000001576

Registered date:17/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 2008/11/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Repetitive transcranial magnetic stimulation over the supplementary motor area, high-frequency stimulation
Repetitive transcranial magnetic stimulation over the supplementary motor area, low-frequency stimulation
Sham stimulation

Outcome(s)

• Primary Outcome: Unified Parkinson's Disease Rating Scale(UPDRS) part 3
• Secondary Outcome: UPDRS part 1,2,4, 5-point scale for daily life and tremor, Apathy scale, 17 item of Hamilton depression scale, Non-Motor Symptoms Questionnaire

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)The patients who underwent the TMS treatment before 2)No implantation of metal in head, except in the mouth 3) Those having heart pacemaker or drug infusion pomp 4) Serious heart disease 5)History of massive cerebral infarction, head injury, brain tumor, or epilepsy 6)Pregnant or intend to be pregnant

Related Information

• Primary Sponsor: Department of neurology, Fukushima medical university
• Secondary Sponsor: Univ: Occupational Environ Health,Tokushima,Kyusyu,Tottori,Tokyo,Hokkaido,Saitama Med,Osaka, Hamamatsu Med,Kinki) Tokyo neurological hos,Kumamoto Kinoh hos, Nagasaki Med center of Neurol
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare