NCT06445595

Brief Summary

The relationship between obesity and the development of chronic headache after traumatic brain injury will be investigated.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 8, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

October 15, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

May 31, 2024

Last Update Submit

October 10, 2024

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • The relationship between Bady Mass Index (BMI) and the development of chronic headache

    BMI is calculated by dividing weight in kilograms by the square of height in metres.

    Postoperative 3 month.

Secondary Outcomes (2)

  • The relationship between the nature of trauma and the development of chronic headache

    Postoperative 3 month.

  • The relationship between patients' education levels and chronic headache

    Postoperative 3 month

Interventions

patients with traumatic brain injuryOTHER

Patients will be contacted by phone

Also known as: Patients will be contacted by phone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

individuals over the age of 18 who suffered a head injury

You may qualify if:

  • Individuals over the age of 18 who suffered a head injury

You may not qualify if:

  • People with severe head trauma
  • Those who do not speak Turkish
  • Those with a history of chronic opioid user
  • Those with alcohol and drug addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Training and Research Hospital

Karaman, Merkez, 70200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Hatice Toprak

CONTACT

05357827688dr.tprk@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asst. prof

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 6, 2024

Study Start

August 8, 2024

Primary Completion

October 1, 2025

Study Completion

January 31, 2026

Last Updated

October 15, 2024

Record last verified: 2024-05

Locations

TU(1)