Patients With Brain Masses/LesionsNCT06401057
Register for Longitudinal Recording of Brain Function
An observational study of Patients With Brain Masses/Lesions, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Brain Masses/Lesions
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to 1 Jan 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with brain masses/lesions (especially tumors (cerebral and non-cerebral, inflammation (infectious and non-infectious), vascular pathologies)
Who may be able to join
- Intracranial lesion
- Age ≥ 18 years
- Written consent to participate in the study
Who cannot join
- Age < 18 years
- Patients not able to give consent
- Patients with intracranial ferromagnetic metal implants
- Patients with implanted electronic devices
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurosurgery Heidelberg University Hospital
Heidelberg, 69120
Maximilan Schwendner, MD, +49 6221 56 6999, maximilian.schwendner@med.uni-heidelberg.de
Sebastian Ille, MD
About this study
Official title: 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.
- Conditions
- Patients With Brain Masses/Lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive status
Higher cognitive functions - determined by the Montreal Cognitive Assessment (MocA)
Measured: until last patient FU up to 48 months
Language status
Language function tested by the Aphasia Check List
Measured: until last patient FU up to 48 months
Motor status
Motor function according to the BMRC scale
Measured: until last patient FU up to 48 months
cortical data
cortical nTMS-Data - distribution according the cortical parellation system
Measured: until last patient FU up to 48 months
Fiber tracts
Volume of fiber tracts
Measured: until last patient FU up to 48 months
Fiber tracts
fractional anisotropy of fiber tracts
Measured: until last patient FU up to 48 months
structural imaging (Connectome)
characteristics of Connectome and Disconnectome analysis (Global Efficiency value)
Measured: until last patient FU up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Brain Masses/LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Schwendner Maximilian, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401057
- Sponsor's protocol ID
- Fun-Reg
- Status last verified
- May 2024
- First submitted
- 7 Jan 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: For selected subgroups, data sharing is possible depending on data safety regulations
Publications
Schwendner M, Kram L, Zhang H, Krieg SM, Ille S. Preoperative nTMS-based mapping of a verbal semantic association task allows for the identification of extensive bihemispheric cortical and subcortical networks. J Neurooncol. 2025 Dec 8;176(1):108. doi: 10.1007/s11060-025-05355-9.
PubMed 41359250
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register for Longitudinal Recording of Brain Function in Patients With Brain Diseases
- ClinicalTrials.gov ID
- NCT06401057
- Acronym / sponsor ID
- Fun-Reg
- Conditions
- Patients With Brain Masses/Lesions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with brain masses/lesions (especially tumors (cerebral and non-cerebral, inflammation (infectious and non-infectious), vascular pathologies)
Key inclusion criteria (3 listed)
- Intracranial lesion
- Age ≥ 18 years
- Written consent to participate in the study
Key exclusion criteria (4 listed)
- Age < 18 years
- Patients not able to give consent
- Patients with intracranial ferromagnetic metal implants
- Patients with implanted electronic devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Derived from this study: PubMed 41359250Schwendner M, Kram L, Zhang H, Krieg SM, Ille S. Preoperative nTMS-based mapping of a verbal semantic association task allows for the identification of extensive bihemispheric cortical and subcortical networks. J Neurooncol. 2025 Dec 8;176(1):108. doi: 10.1007/s11060-025-05355-9.
- Individual participant dataSharing planned: Undecided. For selected subgroups, data sharing is possible depending on data safety regulations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Neurosurgery Heidelberg University Hospital
Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Brain Masses/Lesions, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive status (time frame: until last patient FU up to 48 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.