Last reviewed · How we verify
NCT05909839: STEREO-ET
The STEREO-DBS ET Study: 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation in Essential Tremor
trial testing 7T MRI network analysis for deep brain stimulation in essential tremor in Essential Tremor in 500 participants. Currently enrolling.
9 June 2033
Quick facts
| Lead sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 9 June 2023 |
| Primary completion | 9 June 2033 |
| Estimated completion | 9 June 2033 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- 7T MRI network analysis for deep brain stimulation in essential tremor
Conditions studied
- Essential Tremor — all drugs for Essential Tremor →
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →
Who can join
18 and older, any sex, with Essential Tremor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Rationale: Deep brain stimulation (DBS) of the thalamus is an effective surgical treatment for the patients with advanced essential tremor, despite optimal pharmacological treatment. However, individual improvement after DBS remains variable and 20% of patients experience side effects. To date, DBS-electrode placement and settings in the highly connected thalamus are based on 1,5-Tesla or 3-Tesla MR-images. These low resolution and solely structural modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections. By using structural 7-Tesla MRI (7T MRI) connectivity to visualize (malfunctioning) brain networks, DBS-electrode placement and activation can be individualized. Objective: Primary objective of the study is to determine whether visualisation of cortical projections originating in the thalamus and the position of the DBS electrode relative to these projections using 7T MRI improves tremor as measured by the clinically validated Essential Tremor Rating Assessment Scale after six months of DBS. Secondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life, patient satisfaction with treatment outcome and patient evaluation of treatment burden. Study design: The study will be a single center prospective observational study. Study population: Enrollment will be ongoing from June 2023. Intervention (if applicable): No intervention will be applied. Application of 7T MRI for DBS is standard care and outcome scores used will be readily accessible from the already existing advanced electronic DBS database. Main study parameters/endpoints: The primary outcome measure is the change in motor symptoms as measured by the disease-specific Essential Tremor Rating Assessment Scale (TETRAS). This is measured after 6 months of DBS as part of standard care. The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status, Quality of Life in Essential Tremor Questionnaire, patient satisfaction with the treatment, patient evaluation of treatment burden, operating time, hospitalization time, change of tremor medication, side effects and complications. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The proposed observational research project involves treatment options that are standard care in daily practice. The therapies will not be combined with other research products. Participation in this study constitutes negligible risk according to NFU criteria for human research.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991 -
Current and Emerging Therapeutic Targets for Essential Tremor: A Critical Appraisal of Recent Preclinical and Clinical Studies.
Mukherjee A, Pandey S. · · 2025 · cited 5× · PMID 40415659 · DOI 10.1002/mdc3.70147
Verify or expand the search:
- PubMed search for NCT05909839
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Essential Tremor
Currently open trials in the same condition.
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
- NCT07172295 — Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With R · NA · recruiting
- NCT07016425 — Temporal Interference for Essential Tremor · NA · recruiting
- NCT07049003 — Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor · Phase 1 · recruiting
- NCT06428526 — Impact of Sensory Electrical Stimulation on Sensation and Tremor · NA · active not recruiting
Other Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials
Trials by the same sponsor.
- NCT07301021 — Velopharyngeal Insufficiency After Maxillomandibular Advancement Osteotomy in Obstructive Sleep Apnea Patients · not yet recruiting
- NCT07359482 — sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19 · Phase 3 · not yet recruiting
- NCT07457957 — Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents · NA · not yet recruiting
- NCT06909045 — Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease · NA · recruiting
- NCT07316127 — Immunoadsorption in Autoimmune Long COVID · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05909839 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Last refreshed: 13 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05909839.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing