The hypothesis is that the microlesion effect affects cognitive functioning in Parkinson's disease patients undergoing STN-DBS.
ID
Bron
Verkorte titel
Aandoening
Parkinson's disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoints of the study are the SDMT, Stroop and WAIS part IV Digit Span scores to assess the MLE on cognitive functioning
Achtergrond van het onderzoek
Background an rationale:
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.
Objective:
To determine the presence and predictive value of MLE on cognition after DBS in PD.
Study design:
Prospective observational study.
Study population:
Adult PD-patients undergoing DBS of the STN.
Main study parameters/endpoints:
The primary endpoints of the study are the SDMT, Stroop and WAIS part IV Digit Span scores to assess the MLE on cognitive functioning.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
Doel van het onderzoek
The hypothesis is that the microlesion effect affects cognitive functioning in Parkinson's disease patients undergoing STN-DBS.
Onderzoeksopzet
Various clinical tests will be administered on several time points:
1 day before the surgery: the MoCA
The morning before the surgery: SDMT, Stroop, WAIS IV Digit Span
During the surgery, after electrode insertion: SDMT, Stroop, WAIS IV Digit Span
2 days after the surgery: SDMT, Stroop, WAIS IV Digit Span
12 months after the surgery: the MoCA
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Adult that are selected for DBS in the STN by the multidisciplinary working group
- Oral- and written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL8319 |
Ander register | METC UMCG : METc2020/133 |