REstoring CONsciousness With NEurostimulation of the Central Thalamus: The RECONNECT Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Samuel Snider, MD
Study ID
NCT07228286
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Disorders of Consciousness

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Deep brain stimulation (DBS) electrode implantation — DEVICE
    DBS electrodes implanted to two targets in each thalamus.

Study Details

The RE-CONNECT study is an early feasibility study to establish the safety, feasibility, and efficacy of two central thalamic deep brain stimulation targets in patients with chronic disorders of consciousness.

Key Dates

Start date
Nov 10, 2025
Status verified
Nov 2025
Primary completion
Feb 10, 2029
Completion
Feb 10, 2029

Study Design

Enrollment
2 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: active stimulation
    Each participant will receive a pre-determined sequence of active stimulation to one of two targets or no stimulation over the course of 10 months. This will be divided into two blocks (each with STIM and OFF periods) targeting each of the two thalamic targets. The order will be reversed in participant 2 relative to participant 1.
  • Sham Comparator: no stimulation
    periods of no active stimulation intermixed with active stimulation to one of two targets.

Primary Outcome Measure

Coma Recovery Scale Revised (CRS-R) [ Time Frame: Outcomes will be assessed at baseline and weekly during the 12 month study period. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Samuel Snider
[email protected]
8573072391

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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