Imaging-based registry for treatment quality, quality of life, and symptom control following cerebral neuromodulation procedures

Imaging-based registry for treatment quality, quality of life, and symptom control following cerebral neuromodulation procedures - Neuromodulation Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025490

Enrollment

400

Registered

2021-06-15

Start date

2021-10-19

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G20 G24 G25.0 F33 F33 F42

Interventions

Group 1: Clinical outcomes (especially bleeding complications) and long-term effects of DBS and other neuromodulation therapies will be assessed. For this purpose, parts of the routinely collected dat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. All patients who undergo or have undergone since January 1, 2013, a cerebral neuromodulation procedure (DBS implantation or lesioning procedure) at the University Medical Center Freiburg in collaboration with the Department of Stereotactic and Functional Neurosurgery 2. Written informed consent

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Baseline/descriptive data (all patients): (1) General data (demographic data, duration of illness, handedness). (2) Recording of pre-existing conditions and medications prior to the procedure. (3) Recording of procedure-related bleeding in routine imaging during the post-procedure period. (4) For surgical procedures, recording of data from the intraoperative procedure: type of anesthesia, temporary test electrodes used and their number, results of intraoperative test measurements, implanted stimulation system (type, manufacturer), and date of implantation (electrodes and stimulator), as well as any subsequent surgeries on the stimulation system and their indications. (5) High-resolution magnetic resonance imaging of the skull (3T) including structural anatomical data, as well as diffusion tensor magnetic resonance imaging (DTI) and subsequent fiber tracking to visualize the respective target structure (depending on the implantation site and the indication). (6) Postoperative evaluation of the achieved electrode position relative to the respective target structure using spiral CT or 1.5T MRI (routine). (These pre- and postoperative imaging studies are performed routinely.) (7) Recording of stimulation settings during routine follow-up visits (documentation of primary stimulation after testing individual contacts and all modifications). (8) Calculation/simulation of the electric fields around the stimulation electrode and its position relative to the target structure (EFS = electric field simulation). Measurement of the distance between the field and the target structure as a parameter in the context of field simulations. (9) For lesion-based neuromodulatory procedures without the implantation of a medical device, documentation of the lesion and its connectivity in routine follow-up imaging. (10) Recording of functional disease-specific diagnostics collected as part of routine clinical practice (e.g., neuropsychological testing, PET scans, and gait laboratory examin	—

Measure

Time frame

Baseline/descriptive data (all patients): (1) General data (demographic data, duration of illness, handedness). (2) Recording of pre-existing conditions and medications prior to the procedure. (3) Recording of procedure-related bleeding in routine imaging during the post-procedure period. (4) For surgical procedures, recording of data from the intraoperative procedure: type of anesthesia, temporary test electrodes used and their number, results of intraoperative test measurements, implanted stimulation system (type, manufacturer), and date of implantation (electrodes and stimulator), as well as any subsequent surgeries on the stimulation system and their indications. (5) High-resolution magnetic resonance imaging of the skull (3T) including structural anatomical data, as well as diffusion tensor magnetic resonance imaging (DTI) and subsequent fiber tracking to visualize the respective target structure (depending on the implantation site and the indication). (6) Postoperative evaluation of the achieved electrode position relative to the respective target structure using spiral CT or 1.5T MRI (routine). (These pre- and postoperative imaging studies are performed routinely.) (7) Recording of stimulation settings during routine follow-up visits (documentation of primary stimulation after testing individual contacts and all modifications). (8) Calculation/simulation of the electric fields around the stimulation electrode and its position relative to the target structure (EFS = electric field simulation). Measurement of the distance between the field and the target structure as a parameter in the context of field simulations. (9) For lesion-based neuromodulatory procedures without the implantation of a medical device, documentation of the lesion and its connectivity in routine follow-up imaging. (10) Recording of functional disease-specific diagnostics collected as part of routine clinical practice (e.g., neuropsychological testing, PET scans, and gait laboratory examin

—

Secondary

Measure	Time frame
A distinction between primary and secondary endpoints will not be made in this registry. Rather, a list of equivalent outcome parameters is defined.	—

Countries

Germany

Contacts

Public ContactBastian Sajonz

Universitätsklinikum Freiburg Klinik für Neurochirurgie Abteilung Stereotaktische und Funktionelle Neurochirurgie

bastian.sajonz at uniklinik-freiburg.de+4976127050630

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026