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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02672059
Other study ID # 10/H0706/035
Secondary ID 9755
Status Recruiting
Phase
First received
Last updated
Start date February 2011

Study information

Verified date September 2019
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the context of peripheral neuropathy, we will aim to elucidate correlates between sensory symptoms and:

- Sensory nerve dysfunction.

- Cutaneous small nerve fibre innervation density.

- Psychological co-morbidity.

- Circadian rhythm disturbance co-morbidity.

- Functionality and Quality of life.

- Patterns of human brain activity in a subset of patients that consent to participate in the FMRI (functional magnetic resonance imaging) component of PINS.

2. We will also collect blood samples in this phenotyped cohort of patients. These blood samples coupled with detailed phenotype data will investigate potential gene associations only in the development of painful neuropathy.

3. Knowledge gained from the study will be used to aid the further development of pain questionnaires, designed to detect patients with painful neuropathy.

4.Knowledge gained from the study will be invaluable in informing on-going investigations of painful peripheral neuropathy in animal models, both in our laboratory and others.


Description:

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Study Design


Intervention

Other:
Observation
No intervention

Locations

Country Name City State
United Kingdom Nuffield Department of Clinical Neurosciences Oxford Oxfordshire

Sponsors (4)

Lead Sponsor Collaborator
King's College London Imperial College London, Sheffield Teaching Hospital NHS Foundation Trust, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Phillips TJ, Brown M, Ramirez JD, Perkins J, Woldeamanuel YW, Williams AC, Orengo C, Bennett DL, Bodi I, Cox S, Maier C, Krumova EK, Rice AS. Sensory, psychological, and metabolic dysfunction in HIV-associated peripheral neuropathy: A cross-sectional deep profiling study. Pain. 2014 Sep;155(9):1846-60. doi: 10.1016/j.pain.2014.06.014. Epub 2014 Jun 26. — View Citation

Ramirez JD, Barnes PR, Mills KR, Bennett DL. Intermediate Charcot-Marie-Tooth disease due to a novel Trp101Stop myelin protein zero mutation associated with debilitating neuropathic pain. Pain. 2012 Aug;153(8):1763-8. doi: 10.1016/j.pain.2012.05.015. Epub — View Citation

Schmid AB, Bland JD, Bhat MA, Bennett DL. The relationship of nerve fibre pathology to sensory function in entrapment neuropathy. Brain. 2014 Dec;137(Pt 12):3186-99. doi: 10.1093/brain/awu288. Epub 2014 Oct 27. — View Citation

Segerdahl AR, Xie J, Paterson K, Ramirez JD, Tracey I, Bennett DL. Imaging the neural correlates of neuropathic pain and pleasurable relief associated with inherited erythromelalgia in a single subject with quantitative arterial spin labelling. Pain. 2012 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of neuropathy Toronto Clinical Scoring System of 4 Day 1
Secondary Demographics Main demographic visits Day 1
Secondary Detailed medical history Past clinical records of patients relevant to the current disease status Day 1
Secondary 7-days pain diary Patients will have 7-days pain diaries with a numeric rating scale from 0 to 10 Day 1
Secondary Pain related anxiety Patients will answer the Pain Anxiety Symptoms Scale (PASS-20) Day 1
Secondary Measures of quality of life Patients will answer the 36-Item Short Form Survey -quality of life questionnaire- Day 1
Secondary Measures of sleep interference Sleep quality is assessed through the use of questionnaires Day 1
Secondary Nerve Conduction Studies Neurophysiology will be conducted to assess nerve integrity Day 1
Secondary Sensory Thermal Thresholds Thermal thresholds will be measured in degrees centigrade Day 1
Secondary Sensory Mechanical Detection Thresholds Mechanical Detection Thresholds will be measured in millinewtons Day 1
Secondary Intra-Epidermal Nerve Fibre density Measurement of nerve fibres in the skin of patients - leg or finger- Day 1
Secondary Blood samples - DNA Blood samples coupled with detailed phenotype data will investigate potential gene associations in the development of painful neuropathy Within 6 months of visit
Secondary Blood samples - RNA Blood samples coupled with detailed phenotype data will investigate potential blood markers associations in the development of painful neuropathy Within 18 months of visit
Secondary Blood samples - Serum Blood samples coupled with detailed phenotype data will investigate potential blood markers associations only in the development of painful neuropathy Within 18 months of visit
Secondary Synovium tissue collection for RNA Synovium from around the nerve and tendons coupled with detailed phenotype data will investigate potential blood markers associations only in the development of painful neuropathy Within 18 months of visit
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