Genetics and Phantom Limb Pain
|ClinicalTrials.gov Identifier: NCT01517061|
Recruitment Status : Withdrawn
First Posted : January 25, 2012
Last Update Posted : March 6, 2018
|First Submitted Date||January 24, 2012|
|First Posted Date||January 25, 2012|
|Last Update Posted Date||March 6, 2018|
|Start Date||January 3, 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||SNP frequency between PLP and non-PLP group|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01517061 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Genetics and Phantom Limb Pain|
|Official Title||Integrative Genomic Analysis In Phantom Limb Pain|
- Many people who lose a limb feel pain in the missing limb. This feeling is called phantom limb pain. Researchers do not fully understand what causes this pain. Differences in people's genes may play a role. Comparing the genes of people with and without phantom limb pain may help researchers better understand this feeling, who is likely to develop it, and how to treat it.
- To study whether genetic differences affect phantom limb pain.
- Individuals at least 18 years of age who have lost an arm or leg at least 3 months ago.
The proposed clinical trial will investigate the role of the human genome including genetic variations and gene expression profiles on the development of phantom limb pain (PLP).
Patients will be recruited from military personnel with major limb amputations. A total of one thousand subjects with upper or lower extremity amputations of any level will be enrolled in this study.
Eight hundred subjects with chronic PLP (PLP patient) and 200 patients without PLP (non-PLP patient) will assess the severity of their pain symptom. Each participant will undergo a routine blood draw from which DNA and RNA will be harvested.
Using Affymetrix SNP 6.0 technology, which identifies up to 1 million single nucleotide polymorphisms (SNPs) and 1 million copy number variations in the human genome, the differences in genomic variations between the PLP and the non-PLP patients will be analyzed. An extreme subset of PLP patients will be tested for their quantitative sensory function and profiled gene expression and epigenetic pattern with the Affymetrix Human Exon ST 1.0 and Illumina Genome Analyzer IIx. These integrative genomic analyses using genetic variations, gene expression and epigenetic profile could explain why some amputees experience chronic PLP and some do not. By studying these responses in patient samples, we will evaluate the role of genomic factors in PLP. SNP frequencies, gene expression and epigenetic profiles between PLP and non-PLP groups will be analyzed.
|Study Design||Time Perspective: Retrospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Estimated Completion Date||July 30, 2014|
|Primary Completion Date||Not Provided|
NON PLP GROUP:
-same with PLP group except:
--Experienced PLP less than 10 times total and/or for less than two weeks
BOTH PLP AND NON-PLP GROUPS:
|Ages||18 Years to 60 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Not Provided|
|Removed Location Countries||United States|
|Other Study ID Numbers||120054
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute of Nursing Research (NINR)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 30, 2014|