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A biomarker for deep brain stimulation efficacy in cervical dystonia

A biomarker for deep brain stimulation efficacy in cervical dystonia - A biomarker for deep brain stimulation efficacy in cervical dystonia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49897
Enrollment
30
Registered
2022-02-10
Start date
2022-03-16
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

disorder of muscle tension Dystonia

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to participate in this study, CD patients must meet the following criteria: • Patients with a clinically confirmed diagnosis of idiopathic CD and age >= 18 years; • A life expectancy of at least one year after surgery; • For the patients in the EMG-part: DBS indication approved by the DBS team of the patients hospital. The inclusion criteria for the controls are: • Age- and gender match to the participating patients; • Life expectancy of at least one year after inclusion in the study; • Age >= 18 years.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study. CD patients and controls: • Relevant neurological conditions other than CD; • Previous brain surgery; • Impossibility to stop anticholinergic medication; • Pregnancy or breast feeding; • Exhibition to a radiation dose for medical research, exceeding the maximum annual dose; • Contra-indication for MRI scanning (MR incompatible implants, risk of metal particles in the eyes, tattoos containing red pigments, sensitivity to contrast fluid); • Claustrophobia.

Design outcomes

Primary

MeasureTime frame
The main study parameters are: - The difference in [18F]FEOBV PET binding between CD patients and controls, and its relation to motor- and NMS. - The difference in intermuscular coherence between CD patients and controls, and its relation to motor- and NMS.

Secondary

MeasureTime frame
The secondary endpoint of this study is the intermuscular coherence (pre- and post-DBS) and cholinergic binding (only pre-DBS), and whether pre-operative measurements are predictive for the effect of DBS on motor- and NMS.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)