The primary objective of this research is to determine the prevalence and magnitude of loss of benefit from DBS stimulation in patients who underwent DBS surgery for upper extremity tremor that was refractory to medical management. The secondary…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome variables: Loss of benefit and categorical loss of benefit.
Secondary outcome
Secondary outcome variables: Rebound tremor and overshoot benefit.
Background summary
Loss of DBS benefit is arguably an important research topic in DBS for
medication-refractory tremor. We are seeking a better understanding of the
clinical factors that predict loss of DBS benefit, and we seek a better
understanding of the contribution of tolerance to loss of DBS benefit.
Study objective
The primary objective of this research is to determine the prevalence and
magnitude of loss of benefit from DBS stimulation in patients who underwent DBS
surgery for upper extremity tremor that was refractory to medical management.
The secondary object is to determine the relationship between loss of benefit
and rebound tremor and overshoot benefit.
Study design
This is an investigator-initiated, observational, single-visit, multi-center
study.
Study burden and risks
Due to the very specific aim of this study, only patients suffering from tremor
treated with DBS can participate. The study protocol is safe, non-invasive and
part of standard clinical routines. Switching DBS off might be bothersome for
patients as symptoms will temporarily increase during this time period, which
will be limited to the duration of the study visit.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82457.018.22 |