Motor Neurone Disease Trial, Recruiting NCT03567213 Sponsor: Johns Hopkins University Condition: Motor Neurone Disease
Back to Motor Neurone Disease

Motor Neurone Disease Trial, Recruiting

NCT03567213
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with tetraplegia (paralysis of all four limbs), a brainstem stroke, ALS (Lou Gehrig's disease), or Locked-in Syndrome
  • Your diagnosis or condition began at least one year before joining the trial
  • You have complete or partial paralysis of all four limbs, severe weakness in all four limbs, or severe problems with coordination — which may also include serious difficulty speaking
  • You are between 22 and 70 years old
  • You have been cleared for surgery by your primary doctor and the study's medical team
  • You are able to communicate reliably in some way, such as by moving your eyes
  • You are willing and able to give informed consent to participate
  • A psychologist has confirmed that you have a stable support system and a caregiver who can monitor you throughout the study
  • You are able and willing to travel up to 100 miles to the study location, up to three days per week, for the full length of the study
  • You are able to understand and follow instructions during study sessions
  • You still wish to participate at the time the study begins

Who may not be able to join:

  • Neuropsychological testing shows significant mental health conditions or thinking/memory problems that would affect your ability to consent or fully take part
  • You have attempted suicide or had ongoing thoughts of suicide in the past 12 months
  • You have an implanted device that is not safe with MRI scans, such as a pacemaker, heart defibrillator, spinal cord stimulator, deep brain stimulator, or cochlear implant
  • You have had a problem with substance abuse, dependence on narcotics, or dependence on alcohol in the past 24 months
  • You have medical conditions that make surgery unsafe, such as bone infections, diabetes, hepatitis, autoimmune diseases, epilepsy, serious skin conditions, or blood/heart conditions requiring blood thinners
  • You have other serious, unstable health conditions that could interfere with your participation
  • Brain scans show features that would make it too risky to place the implant in the right location (confirmed by the neurology and neurosurgery team)
  • You have previously had a procedure to repair or replace part of your skull (cranioplasty)
  • You are unable to have an MRI, or you expect to need an MRI during the study period
  • You currently have an active infection or unexplained fever
  • You have serious lung, heart, metabolic, or kidney problems that would make surgery unsafe
  • You are pregnant (checked by a blood test)
  • You are currently breastfeeding, planning to become pregnant, or not using adequate birth control
  • Your vision, even with glasses or contacts, is worse than 20/100
  • You have HIV or AIDS
  • You have existing sores or skin breakdown on your scalp
  • You regularly take steroids or immune-suppressing medications by mouth or through an IV
  • You have had active cancer within the past year or are currently receiving chemotherapy
  • You have had uncontrolled autonomic dysreflexia (a sudden, dangerous rise in blood pressure) within the past 3 months
  • You have a condition causing fluid build-up in the brain (hydrocephalus), with or without a shunt already in place
  • It would be medically unsafe for you to stop taking blood-thinning medications during surgery

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Nathan E Crone, MD, Professor of Neurology

Phone: 410-955-6772

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
14 December 2021
Est. completion
31 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Time to device explantation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov