Brain-Computer Interface for Dystonia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts Eye and Ear Infirmary
Must not be taking: CNS medications
Disqualifiers: Neurological, Psychiatric, Laryngeal, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The researchers will develop and evaluate the use of adaptive closed-loop brain-computer interface therapeutic intervention in laryngeal dystonia.
Will I have to stop taking my current medications?
If you are taking any medications that affect the central nervous system, you will need to stop them to participate in this trial, as those on such medications will be excluded.
What data supports the effectiveness of the treatment Neurofeedback Brain-Computer Interface for Dystonia?
Research shows that brain-computer interface training can help reduce dystonic movements, as seen in a study where patients with writer's cramp showed improvement after using this treatment. Additionally, biofeedback methods have been effective in improving motor control in dystonia, suggesting that similar approaches like neurofeedback therapy could be beneficial.
12345Is the Brain-Computer Interface for Dystonia generally safe for humans?
Research on brain-computer interfaces, including neurofeedback, suggests they are generally safe for humans. Studies involving children with ADHD and other conditions have not reported significant safety concerns, indicating that these treatments are noninvasive and well-tolerated.
13678How is the Neurofeedback Brain-Computer Interface treatment different from other treatments for dystonia?
The Neurofeedback Brain-Computer Interface treatment is unique because it is a noninvasive method that helps patients control their brain activity directly, without using drugs or surgery. It involves training patients to modify their brain signals through feedback, which can reduce symptoms by decreasing neural overexcitation in the brain.
12349Eligibility Criteria
This trial is for adults aged 18-80 with isolated adductor laryngeal dystonia (ADLD), causing voice breaks and strained speech. Participants must be healthy, right-handed native English speakers without neurological or psychiatric issues, not on CNS-affecting meds, and have normal cognitive status. Excluded are those with brain stimulators, impaired senses unrelated to ADLD, history of certain surgeries, pregnant/breastfeeding women, and patients treated with botulinum toxin within the last three months.Inclusion Criteria
You have normal thinking and memory abilities, as tested by the Montreal Cognitive Assessment.
I have been diagnosed with isolated adductor laryngeal dystonia affecting my voice.
You must be right-handed according to a test. Left-handed people won't be included because their brains work differently.
+3 more
Exclusion Criteria
You have a deep brain stimulator implanted.
I am not taking any medications that affect the brain.
I have issues with hearing, vision, or speaking not due to ADLD.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo neurofeedback BCI intervention to correct speech by matching brain patterns to those of whisper
5 days
Daily visits (in-person)
Follow-up
Participants are monitored for changes in voice symptoms after the intervention
4 weeks
Participant Groups
The study is testing a neurofeedback brain-computer interface (BCI) designed to help manage symptoms of laryngeal dystonia. This adaptive closed-loop system will interact directly with the patient's brain activity in an attempt to provide real-time therapeutic interventions tailored to individual needs.
2Treatment groups
Active Control
Placebo Group
Group I: Active neurofeedback BCIActive Control1 Intervention
Patients are presented with symptomatic speech and asymptomatic whisper and, using active EEG-based neurofeedback, are trained to correct their speech by matching their brain patterns to those of whisper. This training is expected to be effective for symptom improvement.
Group II: Sham neurofeedback BCIPlacebo Group1 Intervention
Patients are presented with symptomatic speech and asymptomatic whisper and, using sham EEG-based neurofeedback, are trained to correct their speech by matching their brain patterns to those of whisper. This training is expected not to be effective for symptom improvement.
Neurofeedback Brain-Computer Interface is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Neurofeedback Brain-Computer Interface for:
- Laryngeal dystonia
- Stroke rehabilitation
- Motor disorders
🇪🇺 Approved in European Union as EEG Biofeedback for:
- Anxiety disorders
- Attention deficit hyperactivity disorder (ADHD)
- Chronic pain management
🇨🇦 Approved in Canada as Brain-Computer Interface Neurofeedback for:
- Epilepsy
- Traumatic brain injury rehabilitation
- Neurodevelopmental disorders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts Eye and Ear InfirmaryBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
References
Functional recovery from chronic writer's cramp by brain-computer interface rehabilitation: a case report. [2022]Dystonia is often currently treated with botulinum toxin injections to spastic muscles, or deep brain stimulation to the basal ganglia. In addition to these pharmacological or neurosurgical measures, a new noninvasive treatment concept, functional modulation using a brain-computer interface, was tested for feasibility. We recorded electroencephalograms (EEGs) over the bilateral sensorimotor cortex from a patient suffering from chronic writer's cramp. The patient was asked to suppress an exaggerated beta frequency component in the EEG during hand extension.
Treatment effectiveness of brain-computer interface training for patients with focal hand dystonia: A double-case study. [2020]Neuronal mechanism underlying dystonia is poorly understood. Dystonia can be treated with botulinum toxin injections or deep brain stimulation but these methods are not available for every patient therefore we need to consider other methods Our study aimed to develop a novel rehabilitation training using brain-computer interface system that decreases neural overexcitation in the sensorimotor cortex by bypassing brain and external world without the normal neuromuscular pathway. To achieve this purpose, we recorded electroencephalograms (10 channels) and forearm electromyograms (3 channels) from 2 patients with the diagnosis of writer's cramp and healthy control participants as a preliminary experiment. The patients were trained to control amplitude of their electroencephalographic signal using feedback from the brain-computer interface for 1 hour a day and then continued the training twice a month. After the 5-month training, a patient clearly showed reduction of dystonic movement during writing.
EMG-based visual-haptic biofeedback: a tool to improve motor control in children with primary dystonia. [2013]New insights suggest that dystonic motor impairments could also involve a deficit of sensory processing. In this framework, biofeedback, making covert physiological processes more overt, could be useful. The present work proposes an innovative integrated setup which provides the user with an electromyogram (EMG)-based visual-haptic biofeedback during upper limb movements (spiral tracking tasks), to test if augmented sensory feedbacks can induce motor control improvement in patients with primary dystonia. The ad hoc developed real-time control algorithm synchronizes the haptic loop with the EMG reading; the brachioradialis EMG values were used to modify visual and haptic features of the interface: the higher was the EMG level, the higher was the virtual table friction and the background color proportionally moved from green to red. From recordings on dystonic and healthy subjects, statistical results showed that biofeedback has a significant impact, correlated with the local impairment, on the dystonic muscular control. These tests pointed out the effectiveness of biofeedback paradigms in gaining a better specific-muscle voluntary motor control. The flexible tool developed here shows promising prospects of clinical applications and sensorimotor rehabilitation.
Chronic deep brain stimulation normalizes scalp EEG activity in isolated dystonia. [2019]To investigate cortical activity using scalp EEG in patients with isolated dystonia treated with chronic deep brain stimulation (DBS), on and off stimulation.
A simple and a complex tic (Gilles de la Tourette's syndrome): their response to EEG sensorimotor rhythm biofeedback training. [2019]This study presents a clinical treatment regime for the treatment of tic manifestation, both simple and complex. The response of a case of simple tic and a case of complex tic (Gilles de la Tourette's syndrome) to EEG sensorimotor rhythm biofeedback training are presented. Specifically, the simple and the complex tic, both of long duration, were eliminated via this EEG biofeedback training procedure. It is hypothesized that this exercising of the sensorimotor cortex resulted in increased activation of this cerebrocortical subsystem and was reflected in increased voluntary muscle control and a heightened threshold for random motor discharge, resulting in the elimination of both tics as in the response of cases of epilepsy with motor involvement to EEG sensorimotor rhythm biofeedback training. The additional psychophysiologic sequelae of the complex tic--attention deficit disorder--remediated in the manner of the response of learning-disabled to EEG sensorimotor rhythm biofeedback training.
A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. [2015]A double-blind, randomized, placebo-controlled study was designed to assess the efficacy and safety of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder (ADHD). The study started in August 2008 and ended in July 2012 and was conducted at Karakter Child and Adolescent Psychiatry University Centre in Nijmegen, The Netherlands.
Simplified Attachable EEG Revealed Child Development Dependent Neurofeedback Brain Acute Activities in Comparison with Visual Numerical Discrimination Task and Resting. [2022]The development of an easy-to-attach electroencephalograph (EEG) would enable its frequent use for the assessment of neurodevelopment and clinical monitoring. In this study, we designed a two-channel EEG headband measurement device that could be used safely and was easily attachable and removable without the need for restraint or electrode paste or gel. Next, we explored the use of this device for neurofeedback applications relevant to education or neurocognitive development. We developed a prototype visual neurofeedback game in which the size of a familiar local mascot changes in the PC display depending on the user's brain wave activity. We tested this application at a local children's play event. Children at the event were invited to experience the game and, upon agreement, were provided with an explanation of the game and support in attaching the EEG device. The game began with a consecutive number visual discrimination task which was followed by an open-eye resting condition and then a neurofeedback task. Preliminary linear regression analyses by the least-squares method of the acquired EEG and age data in 30 participants from 5 to 20 years old suggested an age-dependent left brain lateralization of beta waves at the neurofeedback stage (p = 0.052) and of alpha waves at the open-eye resting stage (p = 0.044) with potential involvement of other wave bands. These results require further validation.
A multicenter effectiveness trial of QEEG-informed neurofeedback in ADHD: Replication and treatment prediction. [2022]Quantitative Electroencephalogram-(QEEG-)informed neurofeedback is a method in which standard neurofeedback protocols are assigned, based on individual EEG characteristics in order to enhance effectiveness. Thus far clinical effectiveness data have only been published in a small sample of 21 ADHD patients. Therefore, this manuscript aims to replicate this effectiveness in a new sample of 114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset and to investigate potential predictors of neurofeedback response.
Single-trial classification of feedback potentials within neurofeedback training with an EEG brain-computer interface. [2020]Neurofeedback therapies are an emerging technique used to treat neuropsychological disorders and to enhance cognitive performance. The feedback stimuli presented during the therapy are a key factor, serving as guidance throughout the entire learning process of the brain rhythms. Online decoding of these stimuli could be of great value to measure the compliance and adherence of the subject to the training. This paper describes the modeling and classification of performance feedback potentials with a Brain-Computer Interface (BCI), under a real neurofeedback training with five subjects. LDA and SVM classification techniques are compared and are both able to provide an average performance of approximately 80%.