ClinicalTrials.gg
RecruitingNCT06445595Updated Oct 15, 2024

The Relationship Between Obesity and Chronic Headache

An observational study in Traumatic Brain Injury, sponsored by Karaman Training and Research Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Karaman Training and Research Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 3 months later.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 15 studies in Brain Injuries, Traumatic with a site in Turkey — 5 open to participants now, 5 under way, none of them phase 3. Brain Injuries, Traumatic · Turkey.

Planned enrollment
8th of 12
80 · median 100
Started
2024
with 3 others
Observational
12 of 15
5 open now
Registered
7th of 15
by date
Lead sponsor
1 of 15
Karaman Training and Research Hospital

Among the 15 studies in Brain Injuries, Traumatic with a site in Turkey, this one is the 8th largest by planned enrollment of the 12 observational ones that give a count, is one of 4 that started in 2024, is one of 12 observational ones, and was the 7th registered.

Brain Injuries, Traumatic

1,722 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.

Browse Brain Injuries, Traumatic studies →

Open to participants now

5 of the 15 studies in Brain Injuries, Traumatic with a site in Turkey are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 282 Brain Injuries, Traumatic studies recruiting now, 121 (43%) set no upper age limit and 119 (42%) stop at 75 or younger; 40 take children under 18; 52 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

Read the detailed description

Traumatic brain injury (TBI) can be defined as an injury caused by an external force, particularly a direct blow to the head or exposure to a shock wave. In addition to the well-known consequences of TBI, including cognitive changes, motor deficits and sensory abnormalities, available evidence suggests that acute and chronic pain is also common after TBI. Obesity and TBI can be considered as public health problems with their increasing prevalence in recent years. Chronic pain adds to the already enormous clinical, psychological, social and economic burden of obesity. Developing mechanisms to prevent the development of pain after TBI has attracted the attention of researchers. Obesity is a preventable and modifiable clinical condition. The extent to which obesity may create adverse conditions after TBI remains unclear.

03

Conditions studied

  • Traumatic Brain Injury
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

individuals over the age of 18 who suffered a head injury

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Interventions

  • Otherpatients with traumatic brain injury

    Patients will be contacted by phone

    Also known as: Patients will be contacted by phone

06

What researchers measure

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.

    Time frame: Postoperative 3 month.

Secondary outcomes

  1. The relationship between the nature of trauma and the development of chronic headache

    Head traumas that occur due to different reasons will be examined

    Time frame: Postoperative 3 month.

  2. The relationship between patients' education levels and chronic headache

    Education levels will be defined as primary school, secondary school and university graduate.

    Time frame: Postoperative 3 month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Sharing will be evaluated in cases where the responsible researcher is contacted.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Oct 2025, 13 months after the start.

Of 228 non-industry observational studies under Brain Injuries, Traumatic, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 95. This study's planned 13 months is below that.

Counting every sponsor, half of 250 studies reached it within 49 months; a quarter within 23 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2024
First posted
Jun 6, 2024
StartActual
Aug 8, 2024
Primary completionEst.
Oct 1, 2025
CompletionEst.
Jan 31, 2026
Last update
Oct 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06445595
Lead sponsor
Karaman Training and Research Hospital
Responsible party
HATİCE TOPRAK (asst. prof, Karaman Training and Research Hospital) — Principal investigator
First posted
Jun 6, 2024
Start date
Aug 8, 2024
Primary completion
Oct 1, 2025 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Oct 15, 2024

Study contacts

Hatice Toprak
Contact
dr.tprk@hotmail.com
05357827688

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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