Pseudotumor Cerebri Headache Ten Years Outcome

Headache Long Term Follow-up in Patients Who Suffered From PTCS During Their Childhood

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pseudotumor Cerebri

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Bani Zion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults who were diagnosed with Ptc at their childhood .

Description

Inclusion Criteria:

Patients who were diagnosed with PTC as children

-

Exclusion Criteria:

Patients has other headache types other than PTC

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Research; Patients who were diagnosed with PTC as children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Investigators: Principal Investigator: jacob Genizi, Bnai Zion Medical Center

Publications and helpful links

General Publications

• Smith JL. Whence pseudotumor cerebri? J Clin Neuroophthalmol. 1985 Mar;5(1):55-6. No abstract available.
• Kesler A, Bassan H. Pseudotumor cerebri - idiopathic intracranial hypertension in the pediatric population. Pediatr Endocrinol Rev. 2006 Jun;3(4):387-92.
• Buchheit WA, Burton C, Haag B, Shaw D. Papilledema and idiopathic intracranial hypertension. N Engl J Med. 1969 Apr 24;280(17):938-42. doi: 10.1056/NEJM196904242801707. No abstract available.
• Friedman DI, Jacobson DM. Diagnostic criteria for idiopathic intracranial hypertension. Neurology. 2002 Nov 26;59(10):1492-5. doi: 10.1212/01.wnl.0000029570.69134.1b.
• Baker RS, Baumann RJ, Buncic JR. Idiopathic intracranial hypertension (pseudotumor cerebri) in pediatric patients. Pediatr Neurol. 1989 Jan-Feb;5(1):5-11. doi: 10.1016/0887-8994(89)90002-7.
• Couch R, Camfield PR, Tibbles JA. The changing picture of pseudotumor cerebri in children. Can J Neurol Sci. 1985 Feb;12(1):48-50. doi: 10.1017/s0317167100046588.
• Dhiravibulya K, Ouvrier R, Johnston I, Procopis P, Antony J. Benign intracranial hypertension in childhood: a review of 23 patients. J Paediatr Child Health. 1991 Oct;27(5):304-7. doi: 10.1111/j.1440-1754.1991.tb02544.x.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Headache; outcome
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Intracranial Hypertension; Headache; Pseudotumor Cerebri
• Other Study ID Numbers: BNAI ZION MEDICAL CENTER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No