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A multi-center observational study on the Prevalence of Loss of benefit after DBS for medication-refractory tremor

A multi-center observational study on the Prevalence of Loss of benefit after DBS for medication-refractory tremor - Loss of benefit after DBS in tremor patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51271
Enrollment
20
Registered
2022-12-06
Start date
2023-11-07
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

shaking tremor

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients of any age over 18 who are capable of understanding and granting informed consent. 2. Patients who have undergone unilateral or bilateral DBS surgery for medication-refractory upper extremity tremor at least 5 years prior to recruitment. The upper limit for the time since surgery will be 15 years. Long intervals are specifically welcome. 3. Preoperative diagnosis of ET, ET plus or isolated dystonic tremor as defined by the tremor task force of the international Parkinson and Movement Disorders Society consensus in 2018 (Bhatia et al., 2018). 4. Availability of retrospective clinical baseline and early postoperative data, including tremor scales (see below 4.3.4). 5. Stable tremor medications and stimulation settings for at least 2 months prior to the study visit. 6. Patients must be able to follow the assessment procedure.

Exclusion criteria

Exclusion criteria: 1. Concomitant diseases that may confound the neurological findings. 2. DBS hardware malfunction (e.g., battery or electrode failure). 3. Significant cognitive impairment that may make patient unable to follow assessment procedure.

Design outcomes

Primary

MeasureTime frame
Primary outcome variables: Loss of benefit and categorical loss of benefit.

Secondary

MeasureTime frame
Secondary outcome variables: Rebound tremor and overshoot benefit.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)