Department of Neurosurgery Heidelberg University Hospital
Heidelberg, 69120, Germany
Location status: Recruiting
Recruiting
NCT Number: NCT06401057
Register for Longitudinal Recording of Brain Function
The aim of this observational register study is to establish a registry that completely records and compiles the data from routinely performed technical examinations (navigated transcranial magnetic stimulation, intraoperative neuromonitoring and stimulation, MRI imaging including tractography and connectome) and clinical tests over time (pre-, intra- and postoperative, under adjuvant therapy, as part of follow-up care) of patients with intracranial masses and lesions.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Intracranial lesion
- Age ≥ 18 years
- Written consent to participate in the study
Exclusion criteria
- Age < 18 years
- Patients not able to give consent
- Patients with intracranial ferromagnetic metal implants
- Patients with implanted electronic devices
Treatment and study plan
Primary outcomes
-
Cognitive status
Time frame: until last patient FU up to 48 months
Higher cognitive functions - determined by the Montreal Cognitive Assessment (MocA)
-
Language status
Time frame: until last patient FU up to 48 months
Language function tested by the Aphasia Check List
-
Motor status
Time frame: until last patient FU up to 48 months
Motor function according to the BMRC scale
-
cortical data
Time frame: until last patient FU up to 48 months
cortical nTMS-Data - distribution according the cortical parellation system
-
Fiber tracts
Time frame: until last patient FU up to 48 months
Volume of fiber tracts
-
Fiber tracts
Time frame: until last patient FU up to 48 months
fractional anisotropy of fiber tracts
-
structural imaging (Connectome)
Time frame: until last patient FU up to 48 months
characteristics of Connectome and Disconnectome analysis (Global Efficiency value)
Sponsors and collaborators
Lead sponsor
University Hospital Heidelberg
Other
Registry information
Official study title
Register for Longitudinal Recording of Brain Function in Patients With Brain Diseases
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2028
- First posted
- May 6, 2024
- Registry last updated
- May 6, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.