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Non-invasive BCI-controlled Assistive Devices

Non-invasive Brain-computer Interfaces for Control of Assistive Devices

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether electrical stimulation through the skin can improve training with a brain-computer interface, a tool that uses brain signals to control assistive devices. It studies brain changes as people imagine hand movements during training. It is for people with and without movement disabilities.

Injuries affecting the central nervous system may disrupt the cortical pathways to muscles causing loss of motor control. Nevertheless, the brain still exhibits sensorimotor rhythms (SMRs) during movement intents or motor imagery (MI), which is the mental rehearsal of the kinesthetics of a movement without actually performing it. Brain-computer interfaces (BCIs) can decode SMRs to control assistive devices and promote functional recovery. Despite rapid advancements in non-invasive BCI systems based on EEG, two persistent challenges remain: First, the instability of SMR patterns due to the non-stationarity of neural signals, which may significantly degrade BCI performance over days and hamper the effectiveness of BCI-based rehabilitation. Second, differentiating MI patterns corresponding to fine hand movements of the same limb is still difficult due to the low spatial resolution of EEG. To address the first challenge, subjects usually learn to elicit reliable SMR and improve BCI control through longitudinal training, so a fundamental question is how to accelerate subject training building upon the SMR neurophysiology. In this study, the investigators hypothesize that conditioning the brain with transcutaneous electrical spinal stimulation, which reportedly induces cortical inhibition, would constrain the neural dynamics and promote focal and strong SMR modulations in subsequent MI-based BCI training sessions - leading to accelerated BCI training. To address the second challenge, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to the voluntary activation of the primary motor cortex through MI can help differentiate patterns of activity associated with different hand movements of the same limb by consistently recruiting the separate neural pathways associated with each of the movements within a closed-loop BCI setup. The investigators study the neuroplastic changes associated with training with the two stimulation modalities.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All participants must have normal vision or vision corrected with glasses or contacts.
  • All participants must be able to read and understand English.
  • People without movement disabilities must be in good general health and have no history of brain, nerve, or mental health conditions.
  • People with movement disabilities must have movement problems caused by stroke, spinal cord injury, brain injury, brain tumors, or a listed nerve, muscle, movement, bone, joint, or pain condition.
  • Listed conditions include ALS, spino-cerebellar ataxia, multiple sclerosis, myopathy (muscle disease), cerebral palsy, and pain from injury or nerve problems.
  • People with movement disabilities must be able to give informed consent, meaning they understand the study and agree to join.

Who can't join

  • People with movement disabilities cannot join if attention or thinking problems keep them from focusing for the whole study session.
  • People with movement disabilities cannot join if they take strong medicines that affect the brain or spinal cord, including alertness.
  • People with movement disabilities cannot join if they also have a serious illness, such as a disorder affecting how the body uses food for energy.
  • No participant may have a condition that prevents recording brain or muscle signals or safely giving electrical stimulation. Examples include skin infections, wounds, skin inflammation, or metal implants under the sensors.
  • No participant may have a safety risk listed in guidelines for MRI scans or TMS (magnetic brain stimulation), especially metal implants.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Able-bodied participants: * good general health * normal or corrected vision * no history of neurological/psychiatric disease * ability to read and understand English (Research Personnel do not speak Spanish) 2. Subjects with motor disabilities * motor deficits due to: unilateral and bilateral stroke / spinal cord injury / motor neuron diseases (i.e. amyotrophic lateral sclerosis, spino-cerebellar ataxia, multiple sclerosis) / muscular diseases (i.e. myopathy) / traumatic or neurological pain / movement disorders (i.e. cerebral palsy) / orthopedic / traumatic brain injury / brain tumors * normal or corrected vision * ability to read and understand English * ability to provide informed consent Exclusion Criteria: 1. Subjects with motor disabilities * short attentional spans or cognitive deficits that prevent the subject from concentrating during the whole experimental session * heavy medication affecting the central nervous system (including vigilance) * concomitant serious illness (e.g., metabolic disorders) 2. All participants * factors hindering EEG/EMG acquisition and the delivery of non-invasive electrical stimulation (e.g., skin infection, wounds, dermatitis, metal implants under electrodes) * criteria identified in safety guidelines for MRI and TMS, in particular metallic implants

Study sites (1)

TX