Please sign in to follow a disease.
Brain chip breakthrough: paralysis patients may control devices with thought
NCT ID NCT07521930
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times
Summary
This study tests a brain implant that records and stimulates brain areas to help adults with severe paralysis (from spinal cord injury, ALS, or stroke) control assistive devices like computers or wheelchairs. The main goal is to check safety, and researchers will also see if participants can control two or more devices at once. Only 5 people will take part in this early-stage trial.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), severe ataxia, or disabling motor impairments in both upper limbs, based on neurological exam. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in Locked In Syndrome (LIS) and amyotrophic lateral sclerosis (ALS), including the bulbar variant of ALS. * Clinical diagnosis must be established for the etiology of motor impairments, including brainstem stroke\*, traumatic spinal cord injury (SCI), or progressive and irreversible neuromuscular disease, including muscular dystrophy and motor neuron disease, including amyotrophic lateral sclerosis (ALS). \*Brain stem stroke is defined as an acute onset of neurological deficit with clinical features of brain stem or cerebellar dysfunction lasting more than 24 hours together with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of ischemic infarction or parenchymal hemorrhage. * Candidates with traumatic spinal cord injury must have a complete or incomplete tetraplegia or tetraparesis (ASIA Impairment Scale A, B, C) with an injury level of C6 or higher. * Candidates with tetraplegia or tetraparesis from traumatic SCI and other non-progressive neurological disorders must have an upper extremity motor score (UEMS, ISNCSCI) of 7 or less in each of the upper extremities. Candidate must also have less than antigravity strength (\< 3) throughout the lower limbs. * Candidates with progressive conditions with shortened life expectancy, such as ALS, must have less than antigravity strength (\<3) throughout the upper limbs. * Persistence of motor impairments at least 12 months prior to enrollment if due to a non-progressive neurological cause such as stroke or spinal cord injury * Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants * Ability to communicate reliably, such as through speech or eye movement * Stable psychosocial support system with caregiver capable of monitoring participant throughout the study * Ability and willingness to travel to study location up to five days per week for the duration of the study * Ability to understand and comply with study session instructions * Corrected visual acuity sufficient for use of computer monitor Exclusion Criteria: * Psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities. * Individuals with active implanted devices, including devices that are incompatible with magnetic resonance imaging (MRI). * Contraindications to MRI or anticipated need for an MRI during the study period * Medical conditions contraindicating device implantation surgery (for example significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe) * Chronic anti-coagulation and medical contraindication to temporary suspension for surgery * Medical conditions contraindicating chronic device implantation (e.g. osteomyelitis, chronic infection, poorly controlled diabetes, cancer, severe autoimmune disorder, epilepsy, poor wound healing) * Participants with dental caries and a significant risk of dental or periodontal infection * Chronic oral or intravenous use of steroids or immunosuppressive therapy * Active cancer within the past year or ongoing chemotherapy * Uncontrolled autonomic dysreflexia within the past 3 months * Hydrocephalus with or without an implanted ventricular shunt * Other chronic, unstable medical conditions that could interfere with subject participation. * Persistent suicidal ideation within the past 12 months. * History of substance use disorder within the past year * Pregnancy (confirmation through blood test) * Nursing an infant, planning to become pregnant, or not using adequate birth control
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Amyotrophic lateral sclerosis (ALS) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Johns Hopkins Medicine
RECRUITINGBaltimore, Maryland, 21205, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a massive data registry crack the code of Parkinson's and related brain diseases?
- Can a magnetic helmet slow ALS? trial tests brain stimulation at home
- Can imagining exercise boost brain power after spinal cord injury?
- Spinal implant aims to restore bladder control after paralysis
- Can virtual walking trick the brain into easing chronic pain?
- Ultra-Strong MRI scans could spot ALS earlier