Landmark 140 · Trial in people
EARLYSTIM early DBS
In short
Stimulating the brain early improved quality of life and movement in 251 people, but EARLYSTIM did not test or show slowing of the disease.
- What it is
- Trial in people
- Outcome
- Mixed or early results
- When
- 2013
- Size
- 251 people · Phase 4
- Research lane
- Trial methods & regulation
- Trial registry
- NCT00354133
- Last checked
- 19 Oct 2026
The research record
This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".
Who
Michael Schüpbach, Günther Deuschl and the EARLYSTIM study group (centres in France and Germany). Registered sponsor: the German Parkinson Study Group; funders included the German Ministry of Research.
What happened
Schüpbach et al. (New England Journal of Medicine 2013;368:610–622; NCT00354133). 251 people (mean age 52, disease duration 7.5 years) with early motor complications (wearing-off or dyskinesia) were randomised to subthalamic nucleus stimulation plus drugs (124) or drugs alone (127) for two years. The main measure was quality of life on the PDQ-39 (0–100, higher is worse). It improved 7.8 points with stimulation and worsened 0.2 points without, a difference of 8.0 points (P=0.002). Motor disability, daily living, motor complications (all P<0.001) and time with good mobility without dyskinesia (P=0.01) also favoured stimulation. Serious adverse events: 54.8% with stimulation, 44.1% with drugs alone; 17.7% were related to surgery or the device. Secondary reports of the paper give a 16.4-point advantage in off-medication UPDRS III, and a levodopa-equivalent dose that fell 39% with stimulation and rose 21% without; I did not see these in the paper itself. The registry (checked 19 Oct 2026) lists the trial as Phase 4, enrolment 251, status "unknown", last updated 2018.
Why it moved us toward a cure
It is relevant mainly to trial design: it asked whether stimulation earlier changes quality of life. It builds on the dopamine-circuit understanding in landmark 1. The Vanderbilt pilot (landmark 168) asked the separate question of whether early stimulation changes the course; that is still unanswered.
Outcome
Open as a question; symptomatic only. EARLYSTIM itself gives no evidence of disease modification.
Sources
- Schüpbach et al., NEJM 2013;368:610–622, doi:10.1056/NEJMoa1205158 (abstract read via Europe PMC, PMID 23406026) · ClinicalTrials.gov NCT00354133
- Secondary summary, MDedge (page body not readable; the 16.4-point and 39%/21% figures come from search-result summaries of the paper)
- Not yet verified: the UPDRS III and levodopa-dose figures against the full text; the number of centres.
How it connects
Built on
- builds on Dopamine is missing from the Parkinson's brain · 1960
Led to
None recorded.