TY - JOUR
T1 - Protocol of a randomized controlled trial investigating Deep Brain Stimulation for MOtor symptoms in patients with Parkinson's disease DEmentia (DBS-MODE)
AU - Sisodia, V.
AU - Swinnen, B. E. K. S.
AU - Dijk, J. M.
AU - Verwijk, E.
AU - van Rooijen, G.
AU - Lemstra, A. W.
AU - Schuurman, P. R.
AU - de Bie, R. M. A.
N1 - Funding Information: The DBS-MODE trial is funded by the Stichting Bavalo (charity). The funder had no role in the design, collection, management, analysis, and interpretation of the data; in the writing of the manuscript; and in the decision to submit this manuscript for publication. The funder will have no ultimate authority over any of these activities. Publisher Copyright: © 2023, The Author(s).
PY - 2023/12
Y1 - 2023/12
N2 - BACKGROUND: Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an established treatment for disabling motor symptoms of Parkinson's disease (PD) that persist despite optimal pharmacological treatment. Currently, DBS is not performed if there is concomitant significant cognitive impairment based on concerns of cognitive deterioration, higher complication rate and less functional improvement. However, this has not been investigated so far.METHODS: A single center, prospective, randomized, open-label, blinded end-point (PROBE design) pilot clinical trial is being performed. Patients are eligible for the trial if they have PD dementia (PDD), are able to provide informed consent, and experience disabling motor response fluctuations, bradykinesia, dyskinesia, or painful dystonia, despite optimal pharmacological treatment. In total 44 patients will be randomized to either STN-DBS accompanied by best medical treatment (DBS group) or to best medical treatment alone (BMT group). The primary outcome measure is the change from baseline to 30 weeks on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale part III score in a standardized off-drug phase. The main secondary outcome measures consist of scales assessing cognitive aspects of daily living, neuropsychiatric symptoms and impulsive compulsive disorders. Additional secondary outcome measures include motor signs during on-drug phase, dyskinesia, motor fluctuations, cognitive performance, (severe) adverse events, treatment satisfaction, and caregiver burden. Patients will be followed during 52 weeks after randomization.DISCUSSION: The Deep Brain Stimulation for MOtor symptoms in patients with Parkinson's disease DEmentia (DBS-MODE) trial directly compares the effectiveness and safety of DBS with BMT in patients with PDD.TRIAL REGISTRATION: The DBS-MODE trial has been registered in the International Clinical Trial Registry Platform (NL9361) on the 24 th of March 2021 ( https://trialsearch.who.int/Trial2.aspx?TrialID=NL9361 ).
AB - BACKGROUND: Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an established treatment for disabling motor symptoms of Parkinson's disease (PD) that persist despite optimal pharmacological treatment. Currently, DBS is not performed if there is concomitant significant cognitive impairment based on concerns of cognitive deterioration, higher complication rate and less functional improvement. However, this has not been investigated so far.METHODS: A single center, prospective, randomized, open-label, blinded end-point (PROBE design) pilot clinical trial is being performed. Patients are eligible for the trial if they have PD dementia (PDD), are able to provide informed consent, and experience disabling motor response fluctuations, bradykinesia, dyskinesia, or painful dystonia, despite optimal pharmacological treatment. In total 44 patients will be randomized to either STN-DBS accompanied by best medical treatment (DBS group) or to best medical treatment alone (BMT group). The primary outcome measure is the change from baseline to 30 weeks on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale part III score in a standardized off-drug phase. The main secondary outcome measures consist of scales assessing cognitive aspects of daily living, neuropsychiatric symptoms and impulsive compulsive disorders. Additional secondary outcome measures include motor signs during on-drug phase, dyskinesia, motor fluctuations, cognitive performance, (severe) adverse events, treatment satisfaction, and caregiver burden. Patients will be followed during 52 weeks after randomization.DISCUSSION: The Deep Brain Stimulation for MOtor symptoms in patients with Parkinson's disease DEmentia (DBS-MODE) trial directly compares the effectiveness and safety of DBS with BMT in patients with PDD.TRIAL REGISTRATION: The DBS-MODE trial has been registered in the International Clinical Trial Registry Platform (NL9361) on the 24 th of March 2021 ( https://trialsearch.who.int/Trial2.aspx?TrialID=NL9361 ).
KW - Alzheimer Disease/therapy
KW - Deep Brain Stimulation/adverse effects
KW - Deep brain stimulation
KW - Dementia
KW - Dyskinesias
KW - Humans
KW - Parkinson Disease/therapy
KW - Parkinson’s disease
KW - Prospective Studies
KW - Randomized Controlled Trials as Topic
KW - Randomized controlled trial
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85153539095&partnerID=8YFLogxK
UR - https://pure.uva.nl/ws/files/125536677/12883_2023_3142_MOESM1_ESM.docx
U2 - https://doi.org/10.1186/s12883-023-03142-5
DO - https://doi.org/10.1186/s12883-023-03142-5
M3 - Article
C2 - 37085773
SN - 1471-2377
VL - 23
SP - 160
JO - BMC Neurology
JF - BMC Neurology
IS - 1
M1 - 160
ER -