Unique ID issued by UMIN | UMIN000011495 |
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Receipt number | R000013450 |
Scientific Title | Effect of spinal magnetic stimulation on camptocormia in Parkinson disease |
Date of disclosure of the study information | 2013/08/16 |
Last modified on | 2017/06/07 12:02:00 |
Effect of spinal magnetic stimulation on camptocormia in Parkinson disease
Effect of spinal magnetic stimulation on camptocormia in Parkinson disease
Effect of spinal magnetic stimulation on camptocormia in Parkinson disease
Effect of spinal magnetic stimulation on camptocormia in Parkinson disease
Japan |
Parkinson disease
Neurology |
Others
NO
We assessed the benefits of repetitive trans-spinal magnetic stimulation (rTSMS) on camptocormia, an often treatment-resistant postural abnormality observed in patients with Parkinson disease (PD).
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Thoracolumbar spine flexion angle in the standing position
Thoracolumber spine flexion angle in the seated position
Interventional
Cross-over
Randomized
Cluster
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as a block.
YES
Central registration
2
Treatment
Device,equipment |
Patients were allocated rTSMS first group. PD patients with camptocormia were administered a single trial of rTSMS (a train of 40 stimuli) followed one week later by sham treatment.
Patients were allocated sham first group. PD patients with camptocormia were administered a single trial of sham (a train of 40 stimuli) followed one week later by rTSMS treatment.
50 | years-old | <= |
85 | years-old | >= |
Male and Female
Eligibility criteria included a clinical diagnosis of PD with a disease severity rating of stage 3-4 on the Hoehn and Yahr scale confirmed camptocormia, stable medication use, medical clearance for participation, and willingness to participate in treatment and outcome testing.
Exclusion criteria were current participation in any other behavioral or pharmacologic study or debilitating conditions that would impede full participation.
40
1st name | |
Middle name | |
Last name | Takao Mitsui |
Tokushima National Hospital, National Hospital Organization
Department of Clinical Research
1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031 Japan
0883-24-2161
tmitsui@tokushima-nh.hosp.go.jp
1st name | |
Middle name | |
Last name | Takao Mitsui |
Tokushima National Hospital, National Hospital Organization
Department of Clinical Research
1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031 Japan
0883-24-2161
tmitsui@tokushima-nh.hosp.go.jp
Department of Clinical Research, Tokushima National Hospital, National Hospital Organization
JSPS
Japanese Governmental office
Japan
NO
国立病院機構 徳島病院 (徳島県)
2013 | Year | 08 | Month | 16 | Day |
http://www.tokusimahosp-nho.jp/iin.html
Published
http://www.ncbi.nlm.nih.gov/pubmed/24780955
Of 320 PD patients examined, 37 had concomitant camptocormia and were randomly assigned to either the rTSMS first group (n=19) or sham first group (n=18). Flexion angle in the standing position decreased by a mean of 10.9 degrees (95% CI 8.1 to 13.65) after rTSMS but remained unchanged after sham stimulation (mean, -0.1 degrees; 95% CI -0.95 to 0.71). The flexion angle while sitting (secondary outcome) decreased by 8.1 degrees (95% CI 5.89 to 10.25) after rTSMS, whereas sham treatment had no significant effect (mean, -0.8 degrees; 95% CI -1.62 to 0.05).
Main results already published
2011 | Year | 07 | Month | 14 | Day |
2012 | Year | 04 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 11 | Month | 01 | Day |
2013 | Year | 12 | Month | 01 | Day |
2013 | Year | 12 | Month | 01 | Day |
2013 | Year | 08 | Month | 15 | Day |
2017 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013450
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