Cognitive Impairment and Neuropsychiatric Manifestations of Neurobrucellosis

• Sponsor: Mansoura University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04301752
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

Brucellosis is a common zoonotic infection in many parts of the world including the Mediterranean and Middle Eastern countries.

Neurobrucellosis may develop at any stage of disease and may have widely variable manifestations, including encephalitis, meningoencephalitis, radiculitis, myelitis, peripheral and cranial neuropathies, subarachnoid hemorrhage, and psychiatric manifestations.

Condition or Disease	Intervention/Treatment	Phase
Brucellosis	Diagnostic Test: MoCA

Detailed Description

Brucellosis is a common zoonotic infection in many parts of the world including the Mediterranean and Middle Eastern countries.

Neurobrucellosis may develop at any stage of disease and may have widely variable manifestations, including encephalitis, meningoencephalitis, radiculitis, myelitis, peripheral and cranial neuropathies, subarachnoid hemorrhage, and psychiatric manifestations.

The aimed is to shed light to the obscure areas of diagnosis in neurobrucellosis and have detailed general and neurologic features

Study Design

• Study Type: Observational
• Actual Enrollment: 82 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Cognitive Impairment and Neuropsychiatric Manifestations of Neurobrucellosis
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Neurobrucellosis Brucellosis associated with neuropsychiatric manifestations	Diagnostic Test: MoCA; Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26. Maximum score is 30.
Non-neurobrucellosis Brucellosis not associated with neuropsychiatric manifestations	Diagnostic Test: MoCA; Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26. Maximum score is 30.

Outcome Measures

Primary Outcome Measures

1. MoCA s [24 hours]

   Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26 .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients >18 years of age with laboratory-confirmed brucellosis

Exclusion Criteria:

• Previous neuropsychiatric disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospital	Mansoura		Egypt

Sponsors and Collaborators

• Mansoura University Hospital

Investigators

• Principal Investigator: Esmael M Ahmed, MD, Assistant Prof of Neurology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Esmael, Assistant Prof of Neurology, Mansoura University Hospital
• ClinicalTrials.gov Identifier: NCT04301752
• Other Study ID Numbers: Mansoura University 13
• First Posted: Mar 10, 2020
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmed Esmael, Assistant Prof of Neurology, Mansoura University Hospital: Brucellosis, neuropsychiatric manifestations, cognition
• Additional relevant MeSH terms: Brucellosis; Cognitive Dysfunction

Study Results

No Results Posted as of Mar 18, 2020