Pseudotumor Cerebri Headache Ten Years Outcome | NCT06581185

Studies
Pseudotumor Cerebri Headache Ten Years Outcome

NCT06581185

Sponsor

Bnai Zion Medical Center

Status

Enrolling by invitation

Last Update Posted

Sep 3, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pseudotumor Cerebri

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Actual

Primary Completion Date

Aug 31, 2024Estimated

Completion Date

Aug 31, 2024Estimated

First Submitted Date

Aug 27, 2024

First Submission Date that Met QC Criteria

Aug 29, 2024

First Posted Date

Sep 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2024

Last Update Posted Date

Sep 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Telephone interview on patient who suffered from PTC ten years ago regarding their headache status

Detailed Description

The study will followup using existing medical data from patients previously diagnosed with Pseudotumor cerebri (PTC) using a telephone contact with patients diagnosed more than 10 years ago. After obtaining verbal consent, conducted interviews to collect information on their headaches and quality of life. Data related to PTC was be obtained from medical records. Demographic information was be collected using a questionnaire, the HIT-6 questionnaire will assess headache severity, and a quality of life questionnaire was be used.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Research		Patients who were diagnosed with PTC as children

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
headache outcome HIT-6	How many patients will suffer from headache after recovery from PTC measured by HIT 6 questionnaire	5-10 years

Secondary Outcomes

Measure	Description	Time Frame
Quality of life (QOL)	Is the QOL of patients recovering from PTS related to their headache measured by WHO QOL questionnaire	5-10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who were diagnosed with PTC as children

Exclusion Criteria:

Patients has other headache types other than PTC

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adults who were diagnosed with Ptc at their childhood .

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
jacob Genizi	Bnai Zion Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bani Zion		Haifa			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3156890	Result	Smith JL. Whence pseudotumor cerebri? J Clin Neuroophthalmol. 1985 Mar;5(1):55-6. No abstract available.
16816807	Result	Kesler A, Bassan H. Pseudotumor cerebri - idiopathic intracranial hypertension in the pediatric population. Pediatr Endocrinol Rev. 2006 Jun;3(4):387-92.

ID	Term
D019586	Intracranial Hypertension
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases