Recruiting · registry statusFollowing outcomes after brain stimulation
This register tracks symptom control, quality of life and complications after treatments such as deep brain stimulation.
Learning by observing or collecting information · Study reference: DRKS00025490
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
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- Start (reported date)
- 2021-10-19
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
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Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Age 18 years and over · Ask the team who can join
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
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: None
Full study name & original research details
Official study title
Imaging-based registry for treatment quality, quality of life, and symptom control following cerebral neuromodulation procedures - Neuromodulation Registry
Short title used by the registry
Imaging-based registry for treatment quality, quality of life, and symptom control following cerebral neuromodulation procedures
Original description
Intervention:
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 data of the control visits will be documented in the registry.
Primary outcome:
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 examinations).
(11) Quality of life (EQ-5D-5L).
Outcome measures (PD):
- Mattis Dementia Rating Scale (DRS-2)
- Quality of life disease-specific (PDQ-39)
- Unified Parkinson's Disease Rating Scale (UPDRS) IIII
- Non-motor Symptoms Scale (NMSS)
- Barratt Impulsiveness Scale (BIS-11)
- Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
- Beck's Depression Inventory Revision (BDI II)
- Self-Report Manic Inventory
- L-DOPA Equivalent of Parkinson's Disease Medication (LED)
Target variables (tremor):
- Essential Tremor Rating Assessment Scale (TETRAS)
- Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS)
- Examination of tremor intensity and tremor frequency preoperatively and at postoperative appointments with on and off stimulation
- Mattis Dementia Rating Scale (DRS-2)
- Scale for the assessment and rating of ataxia (SARA)
- Beck's Depression Inventory Revision (BDI II)
- Quality of life disease-specific (QUEST)
Target variables (dystonia):
- For cervical dystonia, Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
- For cervical dystonia Quality of life disease-specific: Craniocervical dystonia questionnaire (CDQ-24)
- For all other dystonias: Unified Dystonia Rating Scale (UDRS)
Target variables (Depression):
- Beck Depression Inventory Revision (BDI-II)
- Montgomery-Asberg Depression Rating Scale (MADRS)
- Hamilton Depression Rating Scale (HAMD-24)
- General Assessment of Functioning (GAF)
- Clinical Global Impression Scale (CGI)
- SF-36 Quality of Life
Target variables (OCD):
- Yale-Brown Obsessive Compulsive Scale (YBOCS)
- Obsessive-Compulsive Inventory – revised (OCI-R)
- Obsessive Beliefs Questionnaire (OBQ-D)
- Beck Depression Inventory Revision (BDI-II)
- Montgomery-Asberg Depression Rating Scale (MADRS)
- General Assessment of Functioning (GAF)
- Clinical Global Impression Scale (CGI)
- SF-36 Quality of Life
Target variables (Neuropathic Pain):
- Visual Analogue Scale (VAS)
- McGill Pain Questionnaire
Secondary outcome:
A distinction between primary and secondary endpoints will not be made in this registry. Rather, a list of equivalent outcome parameters is defined.
Conditions reported: G20
G24
G25.0
F33
F33
F42;Parkinson disease;Dystonia;Essential tremor;Recurrent depressive disorder;Recurrent depressive disorder;Obsessive-compulsive disorder
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Observational
- 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 data of the control visits will be documented in the registry.
- Phases
- Not reported
- Sponsor
- Universitätsklinikum Freiburg Klinik für Neurochirurgie Abteilung Stereotaktische und Funktionelle Neurochirurgie
- Start date reported by registry
- 2021-10-19 (reported)
Registry updated: Not reported · Status last verified by the registry submitter: Not reported
Registry records retrieved 2026-10-14 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Bastian Sajonz · +4976127050630 · bastian.sajonz at uniklinik-freiburg.de
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Facility not reported
Germany
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.