UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005360 |
|---|---|
| Receipt number | 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 12:37:57 |
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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
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
hoshima@med.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005916
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