NCT04125576

Brief Summary

The investigators will observe increased or decreased CBV in patients with thermal injury compared with the CBV in healthy controls.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

November 14, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

October 10, 2019

Last Update Submit

November 13, 2019

Conditions

Keywords

burnneuropathic paincerebral blood volume

Outcome Measures

Primary Outcomes (1)

  • cerebral blood volume

    magnetic resonance imaging(MRI) was used to evaluate cerebral blood volume(CBV) of pain network

    1 week

Secondary Outcomes (1)

  • visual analogue scale

    1 week

Study Arms (2)

Burn patients

The subjects complaine of severe neuropathic pain that is rated at least 5 on the visual analogue scale (VAS), despite treatments with gabapentin medication and other physical modalities.

Diagnostic Test: magnetic resonance imaging(MRI)

Healthy controls

age and sex matched healthy controls

Diagnostic Test: magnetic resonance imaging(MRI)

Interventions

magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) of pain network

Burn patientsHealthy controls

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The patients complained of severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS), despite being treated with drugs and physical therapy for more than 1 week after being admitted to the Department of Rehabilitation Medicine.

You may qualify if:

  • Burn patients
  • severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS).

You may not qualify if:

  • cardiac arrest history
  • history of neurologic disease or brain surgery
  • unstable heart disease or presence of a cardiac pacemaker
  • psychiatric disorder
  • diabetes mellitus
  • abnormal renal function
  • contraindication for MRI
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangang Sacred Heart Hospital

Seoul, Yeong-deungpo-Dong, 150-719, South Korea

RECRUITING

Related Publications (2)

  • Park CH, Seo CH, Jung MH, Joo SY, Jang S, Lee HY, Ohn SH. Investigation of cognitive circuits using steady-state cerebral blood volume and diffusion tensor imaging in patients with mild cognitive impairment following electrical injury. Neuroradiology. 2017 Sep;59(9):915-921. doi: 10.1007/s00234-017-1876-1. Epub 2017 Jul 8.

    PMID: 28689261BACKGROUND
  • Seo CH, Park CH, Jung MH, Jang S, Joo SY, Kang Y, Ohn SH. Preliminary Investigation of Pain-Related Changes in Cerebral Blood Volume in Patients With Phantom Limb Pain. Arch Phys Med Rehabil. 2017 Nov;98(11):2206-2212. doi: 10.1016/j.apmr.2017.03.010. Epub 2017 Apr 6.

    PMID: 28392326BACKGROUND

MeSH Terms

Conditions

NeuralgiaBurns

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Cheong Hoon Seo, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

October 25, 2019

Primary Completion

December 15, 2019

Study Completion

December 20, 2019

Last Updated

November 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations