Register for Longitudinal Recording of Brain Function

Register for Longitudinal Recording of Brain Function in Patients With Brain Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Brain Masses/Lesions

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • Department of Neurosurgery Heidelberg University Hospital
    • Contact: Maximilan Schwendner, MD; Phone Number: +49 6221 56 6999; Email: maximilian.schwendner@med.uni-heidelberg.de
    • Contact: Sebastian Ille, MD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with brain masses/lesions (especially tumors (cerebral and non-cerebral, inflammation (infectious and non-infectious), vascular pathologies)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive status	Higher cognitive functions - determined by the Montreal Cognitive Assessment (MocA)	until last patient FU up to 48 months
Language status	Language function tested by the Aphasia Check List	until last patient FU up to 48 months
Motor status	Motor function according to the BMRC scale	until last patient FU up to 48 months
cortical data	cortical nTMS-Data - distribution according the cortical parellation system	until last patient FU up to 48 months
Fiber tracts	Volume of fiber tracts	until last patient FU up to 48 months
Fiber tracts	fractional anisotropy of fiber tracts	until last patient FU up to 48 months
structural imaging (Connectome)	characteristics of Connectome and Disconnectome analysis (Global Efficiency value)	until last patient FU up to 48 months

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Fun-Reg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: For selected subgroups, data sharing is possible depending on data safety regulations

Drug and device information, study documents

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