Asymmetric STN DBS for FOG in Parkinson's disease: A pilot trial.
Asymmetric stimulation
DBS
Freezing of gait
Parkinson's disease
Subthalamic
Journal
Parkinsonism & related disorders
ISSN: 1873-5126
Titre abrégé: Parkinsonism Relat Disord
Pays: England
ID NLM: 9513583
Informations de publication
Date de publication:
06 2019
06 2019
Historique:
received:
20
10
2018
revised:
20
02
2019
accepted:
20
02
2019
pubmed:
4
3
2019
medline:
10
5
2020
entrez:
4
3
2019
Statut:
ppublish
Résumé
In Parkinson's disease (PD), freezing of gait (FOG) is a highly disabling gait disorder. Though deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an efficient treatment for advanced PD, the management of STN DBS refractory FOG remains challenging. To evaluate the long-term impact on FOG of unilateral stimulation reduction in PD treated with bilateral STN DBS. Patients with bilateral STN DBS for at least one year and refractory FOG were included in a randomized, double blind, cross-over clinical trial. They were randomized to chronic (CHR) vs. experimental (EXP) stimulation (30% amplitude reduction contralateral to the least affected body side), each condition for 4 weeks. Gait and FOG were assessed both in the OFF and ON medication conditions. Primary outcome was the difference in the FOG percentage during gait assessment and in a composite gait score in CHR vs. EXP stimulation. The study was stopped early for futility. Of the 12 patients included, eight dropped out because of re-emerging of PD symptoms. In the four patients who sustained the experimental condition, the FOG percentage did not improve, whether in the OFF (CHR: 13.4% vs. EXP: 16.8%) or in the ON (CHR: 19.5% vs. EXP: 19.8%) medication condition. There was no change in the composite gait score (CHR: 5.5 ± 1.3 vs. EXP: 6.3 ± 3.3). Most patients did not tolerate the unilateral amplitude reduction of STN DBS in the long-term. Moreover, this strategy failed to improve FOG in patients who could sustain the procedure. CLINICALTRIAL. NCT02704195.
Sections du résumé
BACKGROUND
In Parkinson's disease (PD), freezing of gait (FOG) is a highly disabling gait disorder. Though deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an efficient treatment for advanced PD, the management of STN DBS refractory FOG remains challenging.
OBJECTIVE
To evaluate the long-term impact on FOG of unilateral stimulation reduction in PD treated with bilateral STN DBS.
METHODS
Patients with bilateral STN DBS for at least one year and refractory FOG were included in a randomized, double blind, cross-over clinical trial. They were randomized to chronic (CHR) vs. experimental (EXP) stimulation (30% amplitude reduction contralateral to the least affected body side), each condition for 4 weeks. Gait and FOG were assessed both in the OFF and ON medication conditions. Primary outcome was the difference in the FOG percentage during gait assessment and in a composite gait score in CHR vs. EXP stimulation.
RESULTS
The study was stopped early for futility. Of the 12 patients included, eight dropped out because of re-emerging of PD symptoms. In the four patients who sustained the experimental condition, the FOG percentage did not improve, whether in the OFF (CHR: 13.4% vs. EXP: 16.8%) or in the ON (CHR: 19.5% vs. EXP: 19.8%) medication condition. There was no change in the composite gait score (CHR: 5.5 ± 1.3 vs. EXP: 6.3 ± 3.3).
CONCLUSIONS
Most patients did not tolerate the unilateral amplitude reduction of STN DBS in the long-term. Moreover, this strategy failed to improve FOG in patients who could sustain the procedure. CLINICALTRIAL.
GOV IDENTIFIER
NCT02704195.
Identifiants
pubmed: 30826266
pii: S1353-8020(19)30078-1
doi: 10.1016/j.parkreldis.2019.02.032
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02704195']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
94-99Informations de copyright
Copyright © 2019 Elsevier Ltd. All rights reserved.