MIND
(2025)Objective
To compare the safety and efficacy of minimally invasive surgery with medical management alone for spontaneous supratentorial intracerebral hemorrhage (ICH).
Study Summary
• However, exploratory analyses showed an early beneficial effect on disability at 30 days and a reduction in serious adverse events.
Intervention
The MIND trial, a randomized clinical trial, was stopped early due to the publication of a contemporaneous positive ICH trial. Patients were randomized 2:1 to either receive minimally invasive surgery (MIS) within 72 hours of symptom onset along with medical management, or medical management alone.
Inclusion Criteria
Adults aged 18-80 years with a spontaneous supratentorial ICH volume of 20-80 mL, a baseline NIH Stroke Scale score of 6 or higher, and a Glasgow Coma Scale score between 5 and 15.
Study Design
Arms: Minimally Invasive Surgery (MIS) vs. Medical Management (MM).
Patients per Arm: 154 participants were randomized to MIS and 82 to MM.
Outcome
Bottom Line
Minimally invasive surgery (MIS) did not significantly reduce 30-day mortality or improve 180-day disability in patients with supratentorial ICH compared to medical management (MM) alone. However, exploratory analyses showed an early beneficial effect on disability at 30 days and a reduction in serious adverse events.
Major Points
- The MIND trial was an open-label, multicenter randomized clinical trial comparing minimally invasive surgery (MIS) with medical management (MM) alone for spontaneous supratentorial ICH.
- Enrollment was stopped early at 236 participants due to the publication of a contemporaneous positive ICH trial and a subsequent feasibility analysis.
- The primary efficacy outcome, 180-day combined death and disability, showed no significant difference between the MIS and MM groups (OR, 1.03; 96% CI, 0.62-1.72; P=.45).
- The primary safety outcome, 30-day mortality, was similar in both groups (7.2% for MIS vs 9.8% for MM).
- MIS achieved a median hemorrhage volume reduction of 80.7%.
- Exploratory analyses suggested a significant improvement in ordinal modified Rankin Scale (mRS) scores at 30 days for the MIS group, but this benefit was no longer observed at 90 and 180 days.
- Fewer serious adverse events were reported in the MIS group (52.6%) compared to the MM group (68.3%).
Study Design
- Study Type
- Open-label, multicenter randomized clinical trial
- Randomization
- Yes
- Blinding
- Blinded certified assessor conducted the 180-day mRS assessments.
- Sample Size
- 236
- Follow-up
- 180 days.
- Centers
- 32
- Countries
- United States, Canada, Austria, Germany
Primary Outcome
Definition: 180-day combined death and disability via ordinal modified Rankin Scale (mRS) score.
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| - | - | - (0.62-1.72) | .45 |
Limitations & Criticisms
- The trial was stopped early, leading to reduced statistical power to observe true differences between treatment arms.
- Only the 180-day mRS assessments were blinded, potentially introducing bias in earlier assessments.
- Enrollment spanned over 5 years and may have introduced variability.
- Black participants were underrepresented in the trial.
- The trial's follow-up was limited to 180 days, and longer-term data would be informative.
Citation
JAMA Neurol. doi:10.1001/jamaneurol.2025.3151. Published online September 2, 2025.