To determine the presence and predictive value of MLE on cognition after DBS in PD.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints of the study are the SDMT, Stroop and WAIS part IV Digit
Span scores to assess the MLE on cognitive functioning.
Secondary outcome
The MoCA score on the day before the surgery and at 12 months, to assess the
predictive value of perioperative cognitive functioning (MoCA scores are
correlated to SDMT, Stroop and WAIS part IV Digit Span scores to assess this
topic).
Background summary
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an effective
treatment for advanced Parkinson*s disease (PD). In the first days to weeks
after surgery, alleviation of PD symptoms without active stimulation is often
observed, referred to as the microlesion effect (MLE). The presence of MLE on
cognition after DBS surgery has not been studied well, while this non-motor
aspect of PD might be of great importance to the patient.
Study objective
To determine the presence and predictive value of MLE on cognition after DBS in
PD.
Study design
Prospective observational study
Study burden and risks
There are no risks associated with the proposed study.
Assessing cognitive functioning 12 months after DBS surgery leads to better
attention for possible cognitive deficits, which could initiate early
postoperative cognitive deterioration detection and cognitive training to
prevent further cognitive deterioration.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Adults (over the age of 18 years) that are selected for DBS in the STN by the
multidisciplinary working group
Oral- and written informed consent
Exclusion criteria
Unstable internal or other pathologies
Not able to apprehend the consequences of surgical intervention
Depression or other psychiatric instabilities
Dementia (Mattis Dementia Rating Scale (DRS) <120 or Scales for Outcomes of
Parkinson*s disease-cognition (SCOPA-Cog) <20)
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 | NL72672.042.20 |
| Other | NTR NL8319 |