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

Recruiting

• Conditions: shaking; tremor; 10028037

• Registration Number: NL-OMON51271
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome variables: Loss of benefit and categorical loss of benefit.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome variables: Rebound tremor and overshoot benefit.</p><br>