Effects of MR-guided focused ultrasound subthalamotomy on non-motor and motor symptoms of Parkinson’s disease patients with motor fluctuations – a pilot study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023540

Enrollment

Registered

2020-11-30

Start date

2020-12-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

G20

Interventions

Group 1: unilateral MRgFUS subthalamotomy of the more affected body side

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. diagnosis of PD according to MDS diagnosis criteria for = 4 years 2. disabling motor fluctuations despite optimized medical treatment 3. a levodopa response of = 30% in the standardized levodopa-test 4. tremor of any type

Exclusion criteria

Exclusion criteria: 1. neurosurgical contraindications (e.g. brain atrophy, history of abnormal bleeding, cerebro-vascular and cerebro- inflammatory disease) 2. standard MRI-contraindications such as non-MRI compatible implanted metallic devices including cardiac pacemakers 3. severe depression, dementia or unstable psychiatric disease 4. general contraindications (e.g. unstable cardiac status or arterial hypertension, substance abuse)

Design outcomes

Primary

Measure	Time frame
Effects on non-motor and motor symptoms in PD. All endpoints will be exploratory.	—

Secondary

Measure	Time frame
Effects on non-motor and motor symptoms in PD. All endpoints will be exploratory (for detailed description see study protocol).	—

Countries

Germany

Contacts

Public ContactSteffen Paschen

Klinik für Neurologie, UKSH, Campus Kiel

steffen.paschen@uksh.de043150023956

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026