Non-Invasive Brain Stimulation for Traumatic Brain Injury
(SMART Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Minnesota
Disqualifiers: Severe TBI, Visual impairment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a preliminary, prospective interventional study to investigate the feasibility of using transcutaneous alternating current stimulation (TACS) after a traumatic brain injury (TBI) to improve cognitive function and decision-making.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the treatment COGED, External non-invasive stimulation, for traumatic brain injury?
Research shows that non-invasive brain stimulation, like transcranial direct current stimulation (tDCS), can help improve cognitive function and aid recovery in people with traumatic brain injury by enhancing brain plasticity (the brain's ability to adapt and change).
12345Is non-invasive brain stimulation safe for humans?
Non-invasive brain stimulation, including techniques like transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS), has been studied for safety in humans. While more research is needed, current studies suggest it is generally safe, with no major safety concerns reported in trials for traumatic brain injury and other conditions.
678910How is the treatment COGED different from other treatments for traumatic brain injury?
COGED is unique because it uses non-invasive brain stimulation, which means it stimulates the brain from outside the body without surgery. This approach aims to enhance neuroplasticity (the brain's ability to reorganize itself) and improve recovery after a traumatic brain injury, offering a novel way to potentially aid recovery compared to traditional methods.
24111213Eligibility Criteria
This trial is for adults over 18 who've had a mild to moderate traumatic brain injury (TBI) and can perform computerized tests. They must understand the consent process and commit to all appointments. It's not for those with severe TBI, scalp wounds, pacemakers/defibrillators, non-English speakers, or visual issues affecting computer use.Inclusion Criteria
I am over 18, had a mild to moderate brain injury, can do computer tasks, and can follow the study plan.
I am over 18, can do computer tasks, and can attend all appointments.
Exclusion Criteria
I am over 18, speak English, not incarcerated, have no scalp wounds, no TBI, no pacemaker or defibrillator, and can see well enough for computer tasks.
Implanted defibrillator or pacemaker
Visual impairment that hinders ability to complete computerized assessments
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive transcutaneous alternating current stimulation (tACS) or sham stimulation once weekly for six weeks to improve cognitive function and decision-making after traumatic brain injury
6 weeks
6 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing two types of external non-invasive brain stimulation: transcutaneous alternating current stimulation (TACS) and vagal nerve stimulation (tnVNS), aiming to improve cognitive function and decision-making after a TBI.
2Treatment groups
Active Control
Placebo Group
Group I: StimulationActive Control2 Interventions
Stimulation
Group II: ShamPlacebo Group1 Intervention
No stimulation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hennepin County Medical CenterMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
United States Department of DefenseCollaborator
Uniformed Services University of the Health SciencesCollaborator
References
The Effectiveness of Non-Invasive Brain Stimulation Alone or Combined with Cognitive Training on the Cognitive Performance of Patients With Traumatic Brain Injury: Α Systematic Review. [2022]The present study reviewed published evidence on the effectiveness of non-invasive brain stimulation (NIBS) on the cognitive performance of patients with Traumatic brain injury (TBI).
Noninvasive brain stimulation in traumatic brain injury. [2022]To review novel techniques of noninvasive brain stimulation (NBS), which may have value in assessment and treatment of traumatic brain injury (TBI).
Transcranial direct current stimulation (tDCS) effects on traumatic brain injury (TBI) recovery: A systematic review. [2022]Traumatic brain injury (TBI) is a major cause of chronic disability. Less than a quarter of moderate and severe TBI patients improved in their cognition within 5 years. Non-invasive brain stimulation, including transcranial direct current stimulation (tDCS), may help neurorehabilitation by boosting adaptive neuroplasticity and reducing pathological sequelae following TBI.
Noninvasive brain stimulation to modulate neuroplasticity in traumatic brain injury. [2022]To review the use of noninvasive brain stimulation (NBS) as a therapeutic tool to enhance neuroplasticity following traumatic brain injury (TBI).
Efficacy of Non-Invasive Brain Stimulation for Treating Depression in Patients with Traumatic Brain Injury: A Meta-Analysis and Meta-Regression of Randomized Controlled Trials. [2023]This meta-analysis aimed to ascertain the efficacy of non-invasive brain stimulation (NIBS)-comprising repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS)-for depression in traumatic brain injury (TBI) patients.
Cortical Brain Stimulation with Endovascular Electrodes. [2020]Electrical stimulation of neural tissue and recording of neural activity are the bases of emerging prostheses and treatments for spinal cord injury, stroke, sensory deficits, and drug-resistant neurological disorders. Safety and efficacy are key aspects for the clinical acceptance of therapeutic neural stimulators. The cortical vasculature has been shown to be a safe site for implantation of electrodes for chronically recording neural activity, requiring no craniotomy to access high-bandwidth, intracranial EEG. This work presents the first characterization of endovascular cortical stimulation measured using cortical subdural surface recordings. Visual stimulation was used to verify electrode viability and cortical activation was compared with electrically evoked activity. Due to direct activation of the neural tissue, the latency of responses to electrical stimulation was shorter than for that of visual stimulation. We also found that the center of neural activation was different for visual and electrical stimulation indicating an ability of the stentrode to provide localized activation of neural tissue.
A Swine Model of Traumatic Brain Injury: Effects of Neuronally Generated Electromagnetic Fields and Electromagnetic Field Stimulation on Traumatic Brain Injury-Related Changes. [2023]Background and objective Traumatic brain injury (TBI) has been associated with aberrations in neural circuitry attributable to the pathology resulting in electromagnetic field (EMF) changes. These changes have been evaluated in a variety of settings including through novel induction sensors with an ultra-portable shielded helmet and EMF channels with differences identified by comparing pre-injury and post-injury states. Modulation of the EMF has undergone cursory evaluation in neurologic conditions but has not yet been fully evaluated for clinical effects in treatment. Target EMF stimulation using EMF-related changes preoperatively to postoperatively has not yet been attempted and has not been completed using induction sensor technology. Our objectives in this study were twofold: we wanted to test the hypothesis that targeted stimulation using an EMF signal generator and stimulator to abnormal thresholds identified by real-time measurement of EMFs may enable early resolution of EMF changes and treatment of the TBI as modeled through controlled cortical impact (CCI); we also aimed to assess the feasibility of attempting this using real-time measurements with an EMF shielded helmet with EMF channels and non-contact, non-invasive induction sensors with attached EMF transmitters in real-time. Methods A singular Yucatan miniswine was obtained and baseline EMF recordings were obtained. A CCI of TBI and postoperative assessment of cortical EMF in a non-invasive, non-contact fashion were completed. Alterations in EMF were evaluated and EMF stimulation using those abnormal frequencies was completed using multiple treatments involving three minutes of EMF stimulation at abnormal frequencies. Stimulation thresholds of 2.5 Hz, 3.5 Hz, and 5.5 Hz with 1 V signal intensity were evaluated using sinusoidal waves. Additionally, stimulation thresholds using differing offsets to the sine wave at -500 mV, 0 mV, and 500 mv were assessed. Daily EMF and post-stimulation EMF measurements were recorded. EMF patterns were then assessed using an artificial intelligence (AI) model. Results AI modeling appropriately identified differences in EMF signal in pre-injury, post-injury, and post-stimulation states. EMF stimulation using a positive offset of 500 mV appeared to have maximal beneficial effects in return to baseline. Similarly targeted stimulation using thresholds of 2.5 Hz and 5.5 Hz with a positive 500 mV offset at 1 V allowed for recovery of EMF patterns post-injury towards patterns seen in baseline EMF measurements on stimulation day seven (postoperative day 17). Conclusion Stimulation of neural circuits with targeted EMF in a sinusoidal pattern with targeted thresholds after measurement with induction sensors with shielding isolated to a Mu-metal and copper mesh helmet and EMF channels is efficacious in promoting neuronal circuit recovery to preoperative baselines in the TBI miniswine model. Similarly, our findings confirm the appropriateness of this translational model in the evaluation of brain neuronal circuit EMF and that preoperative and post-trauma differences can be appropriately assessed with this technology.
The Effect of Non-Invasive Brain Stimulation (NIBS) on Executive Functioning, Attention and Memory in Rehabilitation Patients with Traumatic Brain Injury: A Systematic Review. [2021]In recent years, the potential of non-invasive brain stimulation (NIBS) for therapeutic effects on cognitive functions has been explored for populations with traumatic brain injury (TBI). However, there is no systematic NIBS review of TBI cognitive impairment with a focus on stimulation sites and stimulation parameters. The purpose of this study was to conduct a systematic review examining the effectiveness and safety of NIBS for cognitive impairment after a TBI. This study was prospectively registered with the PROSPERO database of systematic reviews (CRD42020183298). All English articles from the following databases were searched from inception up to 31 December 2020: Pubmed/MEDLINE, Scopus, CINAHL, Embase, PsycINFO and CENTRAL. Randomized and prospective controlled trials, including cross-over studies, were included for analysis. Studies with at least five individuals with TBI, whereby at least five sessions of NIBS were provided and used standardized neuropsychological measurement of cognition, were included. A total of five studies met eligibility criteria. Two studies used repetitive transcranial magnetic stimulation (rTMS) and three studies used transcranial direct current stimulation (tDCS). The pooled sample size was 44 individuals for rTMS and 91 for tDCS. Three of five studies combined cognitive training or additional therapy (computer assisted) with NIBS. Regarding rTMS, target symptoms included attention (n = 2), memory (n = 1), and executive function (n = 2); only one study showing significant improvement compared than control group with respect to attention. In tDCS studies, target symptoms included cognition (n = 2), attention (n = 3), memory (n = 3), working memory (WM) (n = 3), and executive function (n = 1); two of three studies showed significant improvement compared to the control group with respect to attention and memory. The evidence for NIBS effectiveness in rehabilitation of cognitive function in TBI is still in its infancy, more studies are needed. In all studies, dorsolateral prefrontal cortex (DLPFC) was selected as the stimulation site, along with the stimulation pattern promoting the activation of the left DLPFC. In some studies, there was a significant improvement compared to the control group, but neither rTMS nor tDCS had sufficient evidence of effectiveness. To the establishment of evidence we need the evaluation of brain activity at the stimulation site and related areas using neuroimaging on how NIBS acts on the neural network.
Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham-controlled PREMIUM II trial. [2022]Evaluate the efficacy and safety of non-invasive vagus nerve stimulation for migraine prevention.
NEUROPLASTICITY AND BRAIN STIMULATION: DEVELOPING INTERVENTIONS TO PROMOTE RECOVERY FROM STROKE AND TRAUMATIC BRAIN INJURY. [2023]This article's purpose is to explore how "non-invasive brain stimulation" (NBS) can be used to treat "traumatic brain injury" (TBI) and promote neuroplasticity. Along with the pathophysiological processes that occur after a TBI, "transcranial direct current stimulation" (tDCS) and "transcranial magnetic stimulation" (TMS) are described. These processes are based on a study of the relevant literature. Individualized treatment plans are required because the pathophysiological processes that result from TBI change over time. Given their neurophysiological effects, TMS and tDCS may be used to (a) significant suppression of post-traumatic cerebral hyper excitability; (b) control synaptic plasticity over the long run to prevent unfavorable outcomes; and (c) in addition to other forms of treatment such as physical and behavioral, assist some neural networks to reorganize and consolidate their learning. These treatments have the potential to reduce the disabling symptoms of brain injury.Animal and human research show that NBS may help reduce the severity of injuries and increase plastic changes in lesioned brain tissue, both of which are necessary for the successful acquisition of new knowledge and the restoration of lost functions. However, at present, this evidence is mostly speculative. The relevance of NBS in TBI, further elucidating its therapeutic benefits, and defining appropriate stimulation levels all need investigations in TBI patients due to safety concerns.
Noninvasive cortical stimulation in neurorehabilitation: a review. [2016]The purpose of this special communication is to provide an overview of noninvasive cortical stimulation techniques, the types of mechanistic information they can provide, and the ways their use is contributing to our understanding of current models of neurorehabilitation. The focus is primarily on studies using noninvasive cortical stimulation techniques in the human motor system. Noninvasive cortical stimulation techniques are useful tools in the field of neurorehabilitation that are being actively used to test proposed models of functional recovery after neurologic injury. They can provide insight into the physiologic mechanisms of functional recovery and are under investigation as a possible auxiliary intervention to modulate cortical excitability and enhance training effects.
Consensus: Motor cortex plasticity protocols. [2016]Noninvasive transcranial stimulation is being increasingly used by clinicians and neuroscientists to alter deliberately the status of the human brain. Important applications are the induction of virtual lesions (for example, transient dysfunction) to identify the importance of the stimulated brain network for a certain sensorimotor or cognitive task, and the induction of changes in neuronal excitability, synaptic plasticity or behavioral function outlasting the stimulation, for example, for therapeutic purposes. The aim of this article is to review critically the properties of the different currently used stimulation protocols, including a focus on their particular strengths and weaknesses, to facilitate their appropriate and conscientious application.
Clinical utility of brain stimulation modalities following traumatic brain injury: current evidence. [2022]Traumatic brain injury (TBI) remains the main cause of disability and a major public health problem worldwide. This review focuses on the neurophysiology of TBI, and the rationale and current state of evidence of clinical application of brain stimulation to promote TBI recovery, particularly on consciousness, cognitive function, motor impairments, and psychiatric conditions. We discuss the mechanisms of different brain stimulation techniques including major noninvasive and invasive stimulations. Thus far, most noninvasive brain stimulation interventions have been nontargeted and focused on the chronic phase of recovery after TBI. In the acute stages, there is limited available evidence of the efficacy and safety of brain stimulation to improve functional outcomes. Comparing the studies across different techniques, transcranial direct current stimulation is the intervention that currently has the higher number of properly designed clinical trials, though total number is still small. We recognize the need for larger studies with target neuroplasticity modulation to fully explore the benefits of brain stimulation to effect TBI recovery during different stages of recovery.