Among the dystonias defined by Fahn in 1988, those diagnosed as primary oromandibular, eyelid, cervical, upper limb, unilateral, or generalized dystonia as classified by Albanese et al. in 2013. Also, those clinically diagnosed as having hemifacial spasm or upper and lower limb spasticity. Patients who visited our outpatient department were enrolled. 2) Patients who have given written informed consent to participate in the study 3) Individuals who have not received botulinum treatment
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Eligibility Criteria 1) Among the dystonias defined by Fahn in 1988, those diagnosed as primary oromandibular, eyelid, cervical, upper limb, unilateral, or generalized dystonia as classified by Albanese et al. in 2013. Also, those clinically diagnosed as having hemifacial spasm or upper and lower limb spasticity. Patients who visited our outpatient department were enrolled. 2) Patients who have given written informed consent to participate in the study 3) Individuals who have not received botulinum treatment in the past three months. 4) Individuals who have not altered their oral medication in over three months.
Exclusion criteria
Exclusion criteria: Under 15 years of age 2) Those with other diseases 3) Those with serious renal or hepatic impairment 4) Pregnant women and women of childbearing age who have not taken effective measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Before treatment (prior to enrollment), the prescribing doctor will take a video and record objective symptoms ( "pre-registration video"). Prior to tratment, a diagnostic doctor (video doctor) will asses motor an d psychiatric symptoms using scales such as the Burke-Fahn-Marsden Dystonia Movement Scale (BFMDMS) and YBOCS, The disgnodtic doctor will videotape and evaluates the objective symptoms before treatment ("Post-registration video")The prescribing doctor prescribes medication and instructs the patinet to visit the hospital in two weeks. Two weeks after the start of the study, a diagnostic doctor will assess motor and psychiatric symptoms using scale such as the BFMDMS and YBOCS. The diagnostic doctor will nideotape and evaluates the objective symptoms " two weeks" after the start of the trial. The prescribing docor prescribes medication and instructs the patient to visit the doctor in two weeks. Four weeks after the start of the study, a diagnostic doctor will assess motor and psychiatic symptoms using scales such as BFDMS and YBOCS. The diagnostic doctoe will videotape and evaluates the objective symptoms"four weeks"after the start of th etrial. The prescibing doctor prescribes medication and instructs the patients to visit the doctor in two weeks. Eight weeks after the start of the study, a diagnostic doctor will assess motor and psychiatic symptoms using scales such as BFDMS and YBOCS. The diagnostic doctoe will videotape and evaluates the objective symptoms"eight weeks"after the start of the trial. The prescibing doctor will check for side effects and complete the tratmenta trial. If the patient wishes, the same oral tratment is continued, and motor and psychiatric symptoms are evaluated at a late date (assuming one year later) using the same evaluation methods("Evaluation of the efficacy on long-term tratment") | — |
Countries
Japan
Contacts
Kumamoto Neurosurgical Hospital Neurosurgery