Lancet Neurology: Treatment of Parkinson's disease (INTREPID) with multiple independent constant flow control devices to stimulate deep brain tissue in the hyalthesis of the hyalthesis: a multi-center, double-blind, randomized controlled study

Parkinson's disease (PD) is a common neurological degenerative disease that is common in the elderly.
pathological change is the degenerative death of neurons of the central brain blackness dopamine (DA), which causes a significant reduction in the synth DA content and disease.
exact cause is not yet known.
, deep brain stimulation (DBS) in the hyalpsy nucleus has been shown to improve motor symptoms and quality of life in people with Parkinson's disease, according to research.
study, a double-blind, false control, randomized controlled trial focused on the evaluation of hypothyclyctic substrate DBS in patients with Parkinson's disease using a new multi-independent contact current control (MICC) device.
study was conducted at 23 implant centers in the United States.
key inclusion criteria are those between the ages of 22 and 75 who are diagnosed with primary Parkinson's disease with exercise symptoms of more than five years and who use anti-Parkinson's drugs steadily within 28 days of their consent.
dbs implanted in the double-sided hyalthyclyceria core in patients who met screening criteria.
patients were randomly assigned at a 3:1 scale and received active therapeutic stimulation settings (active groups) or sub-therapeutic stimulation settings (control groups) during the blind period of 3 months.
during the three-month blind trial, either the patient or the evaluater was aware of the allocation of the treatment group.
The main results of this study were differences in the average daily waking time of patients in the active and control groups over the three months from baseline examination to random grouping, with well-controlled symptoms, no significant movement disorders, and no increase in anti-Parkinson's drugs.
after the blind phase, all patients received positive treatment for up to 5 years during the open label period.
the main and secondary results based on treatment intent.
all patients who provide informed consent are included in the safety analysis.
current findings are based on a pre-specified interim analysis of the top 160 randomly assigned patients.
313 patients were included in the study between 17 May 2013 and 30 November 2017.
of the 313 patients, 196 (63%) received DBS implants and 191 (61%) were randomly assigned.
121 (76%) of the 160 patients in the interim analysis were randomly assigned to the active group and 39 (24%) were assigned to the control group.
the average change in the activity group and the control group from baseline examination (after implantation) to randomization increased in time, with no significant movement disorders, with differences of 3.03h (SD 4.52, 95% CI 1.3-4.7; p-lt;0.0001).
20 (13%) patients had 26 severe adverse events during the three-month blind period.
, 18 incidents and 8 incidents were reported by the activity group and the control group, respectively.
1 in 196 patients died before the random grouping, but this was not related to surgery, instruments or stimuli.
, the multi-center, forward-looking, double-blind, randomized controlled trial evaluated the hyalthyclycical MICE-DBS system and showed significant improvements in motor function and quality of life in people with Parkinson's disease while maintaining acceptable safety.
the limitations of this study design, future studies will need to fully assess the benefits of MICKC technology for clinical outcomes.
Vitek, Jerrold L et al. Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study. The Lancet Neurology, Volume 19, Issue 6, 491 - 501 Network Source: Web Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Mets Medicine" or "Source: MedSci Original" are owned by Mets Medicine and are not authorized to be reproduced by any media, website or individual, and are authorized to be reproduced with the words "Source: Mays Medicine".
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