Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain

Pelvis Pain Chronic Clinical Trial

Official title:

Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02160483
• Other study ID #: 2013/728/D
• Status: Withdrawn
• Phase: N/A
• First received: May 25, 2014
• Last updated: August 18, 2017
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2017
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Functional magnetic resonance imaging in women with chronic pelvic pain using arterial spin labelling, functional connectivity, diffusion tensor imaging and magnetic resonance spectroscopy.

Description:

Multimodal magnetic resonance neuroimaging will be utilised. Arterial spin labelling is tightly coupled with cerebral metabolism and can be used as a marker of neural activity. Resting state magnetic resonance imaging which measures synchronous activity across the brain, allows detection of functional connectivity of intrinsic brain network. Diffusion tensor imaging detects the anisotropic water diffusion in axonal fibres can provide information on connectivity and fibre tracts. Magnetic resonance spectroscopy would enable the levels of neurotransmitter to be elucidated.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic pelvic pain

• Endometriosis

Exclusion Criteria:

• Contraindication to magnetic resonance imaging

Related Conditions & MeSH terms

• Adenomyosis
• Endometriosis
• Endometriosis of Uterus
• Pelvic Pain
• Pelvis Pain Chronic

Intervention

Other:
• Functional magnetic resonance imaging
3 Tesla magnetic resonance imaging

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	Duke-NUS Graduate Medical School

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with increase in insula anterior cingulate cortex signal on magnetic resonance imaging	Magnetic resonance imaging using arterial spin labelling, functional connectivity, diffusion tensor imaging, magnetic resonance imaging	1 hour
Secondary	Number of subjects in psychological testing with increased anxiety, depression and pain catastrophizing scores	Anxiety, depression and pain catastrophizing scales used for psychological testing	1 hour