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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005360
Receipt No. R000005916
Scientific Title Effect of subthalamic nucleus stimulation for pain related to Parkinson's disease
Date of disclosure of the study information 2011/04/01
Last modified on 2012/10/15

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Basic information
Public title Effect of subthalamic nucleus stimulation for pain related to Parkinson's disease
Acronym STN stimulation for PD-related pain
Scientific Title Effect of subthalamic nucleus stimulation for pain related to Parkinson's disease
Scientific Title:Acronym STN stimulation for PD-related pain
Region
Japan

Condition
Condition Parkinson disease
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effecacy of STN stimulation on pain-related to Parkinson disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Data are collected from this cohort prospectively. All patients describe the severity of their pain according to a visual analogue scale (VAS; 0-10.0 points) preoperatively and at 2 weeks, 6 and 12 months postoperatively.
Key secondary outcomes Unified Parkinson's Disease Rating Scale (UPDRS) is scored during the on-period and off-period with sustaining anti-parkinsonian agents. The levodopa-induced dyskinesias (LID) are categorized into three groups; off-period, diphasic, and on-period dyskinesia. The dyskinesia severity rating scale is employed to evaluate the severity of each of LID, scoring the dyskinesia in 6 body parts (neck, trunk, and each of the 4 extremities) on a 5-point scale (ranging from 0 to 4; e.g. 0=absent, 4=severe). All patients are also assessed for their mood using the Hamilton depression scale and their cognitive function by using Mini-Mental Status Examinations.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Advanced idiopathic PD is diagnosed in all patients and refer to us by neurologists with an intimate knowledge of the pharmacological treatment of PD. Our surgical indication criteria for STN stimulation is clinically diagnosed advanced idiopathic PD which demonstrate evidence of a good response to levodopa, and a Hoehn and Yahr staging that is within the range of stages III-V during the off-period and stage III or less in the best on-condition despite treatment with optimal pharmacological therapies. by our group
Key exclusion criteria Patients with major depression or cognitive dysfunction (Mini-Mental Status Examination score < 23) are excluded as candidates for surgery.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Oshima
Organization Nihon University School of Medicine
Division name Neurological Surgery
Zip code
Address 30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo
TEL 03-3972-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Oshima
Organization Nihon University School of Medicine
Division name Neurological Surgery
Zip code
Address 30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo
TEL 03-3972-8111
Homepage URL
Email hoshima@med.nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日本大学医学部附属板橋病院(東京)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://thejns.org/doi/full/10.3171/2011.7.JNS11158?prevSearch=&searchHistoryKey=
Number of participants that the trial has enrolled
Results
Several types of pain related to PD, the categories of which were based on a modification of two previous classifications (Ford and Honey), can occur in such patients: 1) musculoskeletal pain, 2) dystonic pain, 3) somatic pain exacerbated by PD, 4) radiculo-peripheral neuropathic pain, and 5) central pain. The overall mean VAS score was significantly decreased by 75% and 69% at 2 weeks and 6 months postoperatively (p  0.001). The mean VAS score at 12 months was also decreased by 80%; however, 6 instances of pain (3 of somatic back pain and 3 of radiculo-peripheral neuropathic pain) required additional spinal surgery to alleviate their severity. The results were analyzed using Wilcoxon's signed-ranks test, and demonstrated a significant reduction in VAS scores at all follow-up assessment times (p<0.001). Musculoskeletal pain and dystonic pain were well alleviated by STN stimulation. In contrast, somatic pain exacerbated by PD and peripheral neuropathic pain originating from lumbar spinal diseases, such as spondylosis deformans and/or canal stenosis, often deteriorated postoperatively despite their motor disability being attenuated. Patients with central pain were poor responders. 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2005 Year 07 Month 01 Day
Last follow-up date
2009 Year 01 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 01 Month 01 Day
Date analysis concluded
2011 Year 01 Month 01 Day

Other
Other related information prospective study

Management information
Registered date
2011 Year 04 Month 01 Day
Last modified on
2012 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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