Brain-Computer Interface for Dystonia

Overseen By Kristina Simonyan, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: CNS medications

Disqualifiers: Neurological, Psychiatric, Laryngeal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a brain-computer interface (BCI) can assist individuals with laryngeal dystonia, a condition causing involuntary voice spasms during speech. Participants will train to adjust their brain activity to enhance speech patterns. The trial includes two groups: one using the actual neurofeedback BCI (Neurofeedback Brain-Computer Interface) and another using a sham (placebo) version for comparison. The study seeks individuals diagnosed with isolated adductor laryngeal dystonia, which causes voices to sound strained or break during vowel sounds. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatments for voice disorders.

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 prior data suggests that this brain-computer interface is safe for treating laryngeal dystonia?

Research has shown that brain-computer interfaces (BCIs) could help treat conditions like dystonia, which affects movement. BCIs have been safely used for other conditions, such as stroke and Parkinson's disease. One study on EEG-based neurofeedback, a type of BCI, found it can help with movement problems like dystonia.

While detailed safety data is lacking, BCIs used in similar conditions appear generally safe. These studies have not reported serious side effects, suggesting that the neurofeedback BCI in this trial might be safe for participants. However, discussing any concerns with the trial team is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brain-Computer Interface (BCI) for dystonia because it offers a novel way to potentially improve symptoms by directly training the brain. Unlike traditional treatments like oral medications or botulinum toxin injections that target muscle symptoms, this approach uses neurofeedback to help patients adjust their brain patterns to improve speech. The active neurofeedback BCI leverages EEG technology to provide real-time brain activity feedback, aiming to align brain function with symptom-free states like whispering. This technique could pave the way for more personalized and non-invasive interventions, offering new hope for individuals with dystonia.

What evidence suggests that this neurofeedback brain-computer interface is effective for dystonia?

Research has shown that brain-computer interfaces (BCIs) using neurofeedback can assist people with neurological disorders. These BCIs provide real-time feedback to the brain, potentially improving control over movements. In this trial, participants will join different treatment arms. The active neurofeedback BCI arm aims to help users modify their brain activity to enhance speech in laryngeal dystonia, a condition affecting speech. This approach holds promise by teaching the brain new ways to control the muscles used for speaking. Early research suggests that using BCIs in this manner can improve symptoms in conditions like dystonia. In contrast, the sham neurofeedback BCI arm is not expected to improve symptoms. ^{1 3 6 7 8}

Who Is on the Research Team?

Kristina Simonyan, MD, PhD

Principal Investigator

Massachusetts Eye and Ear

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Neurofeedback Brain-Computer Interface

Trial Overview 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.

How Is the Trial Designed?

Group I: Active neurofeedback BCI Active Control 1 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 BCI Placebo Group 1 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

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

Published Research Related to This Trial

EEG sensorimotor rhythm biofeedback training effectively eliminated both simple and complex tics in two cases, suggesting a promising treatment approach for tic disorders.

The training likely enhanced voluntary muscle control and reduced random motor discharges by activating the sensorimotor cortex, which may also help address associated conditions like attention deficit disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple and a complex tic (Gilles de la Tourette's syndrome): their response to EEG sensorimotor rhythm biofeedback training. Tansey, MA.[2019]

A pilot study involving a patient with chronic writer's cramp demonstrated that a brain-computer interface can help reduce excessive beta frequency activity in the brain, leading to improved handwriting function.

The patient underwent biweekly training for 5 months without any adverse effects, indicating that this noninvasive treatment is safe and may offer a new approach for managing dystonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional recovery from chronic writer's cramp by brain-computer interface rehabilitation: a case report. Hashimoto, Y., Ota, T., Mukaino, M., et al.[2022]

In a study involving 41 children with ADHD, EEG neurofeedback did not show a significant improvement in ADHD symptoms compared to placebo neurofeedback, indicating it may not be an effective treatment option.

Both treatment groups experienced a general improvement in ADHD symptoms over time, but there were no significant differences between the groups, and no clinically relevant side effects were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. van Dongen-Boomsma, M., Vollebregt, MA., Slaats-Willemse, D., et al.[2015]

A new two-channel EEG headband was developed that is safe, easy to attach and remove, and does not require electrode paste, making it suitable for frequent use in monitoring neurodevelopment.

Preliminary tests with a visual neurofeedback game showed age-dependent changes in brain wave activity among 30 children aged 5 to 20, suggesting potential for using this device in educational and neurocognitive development applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simplified Attachable EEG Revealed Child Development Dependent Neurofeedback Brain Acute Activities in Comparison with Visual Numerical Discrimination Task and Resting. Oda, K., Colman, R., Koshiba, M.[2022]

The study introduces a novel biofeedback system that uses electromyogram (EMG) data to provide visual and haptic feedback during upper limb movements, aiming to improve motor control in patients with primary dystonia.

Results indicate that this biofeedback significantly enhances muscular control in dystonic patients, suggesting its potential as an effective tool for sensorimotor rehabilitation and clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMG-based visual-haptic biofeedback: a tool to improve motor control in children with primary dystonia. Casellato, C., Pedrocchi, A., Zorzi, G., et al.[2013]

In a study of 114 ADHD patients using QEEG-informed neurofeedback, response rates were high, with 85% showing at least a 25% reduction in symptoms and 55% achieving remission, replicating previous findings from a smaller sample.

The study suggests that individual EEG characteristics can help tailor neurofeedback protocols, potentially enhancing treatment effectiveness, while also identifying predictors of remission such as baseline hyperactivity levels and specific EEG markers in different genders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter effectiveness trial of QEEG-informed neurofeedback in ADHD: Replication and treatment prediction. Krepel, N., Egtberts, T., Sack, AT., et al.[2022]

A novel rehabilitation training using a brain-computer interface was developed to help reduce neural overexcitation in the sensorimotor cortex, which is linked to dystonia.

In a preliminary study with 2 patients diagnosed with writer's cramp, one patient showed a clear reduction in dystonic movements after 5 months of training, indicating potential efficacy of this method as an alternative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment effectiveness of brain-computer interface training for patients with focal hand dystonia: A double-case study. Hashimoto, Y., Ota, T., Mukaino, M., et al.[2020]

Neurofeedback therapies can help treat neuropsychological disorders and improve cognitive performance, with feedback stimuli being crucial for guiding brain rhythm learning.

In a study involving five subjects, the use of a Brain-Computer Interface (BCI) achieved an average classification performance of about 80% when modeling and classifying performance feedback, demonstrating the potential for real-time monitoring of training compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-trial classification of feedback potentials within neurofeedback training with an EEG brain-computer interface. López-Larraz, E., Iterate, I., Escolano, C., et al.[2020]

Chronic deep brain stimulation (DBS) in patients with isolated dystonia normalizes alpha power in the motor cortex during stimulation, suggesting it effectively reduces abnormal brain activity associated with the condition.

When DBS is turned off, there is an increase in alpha power and coherence between the motor cortices, indicating that DBS helps to desynchronize brain networks, which is a key mechanism in treating movement disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic deep brain stimulation normalizes scalp EEG activity in isolated dystonia. Miocinovic, S., Miller, A., Swann, NC., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9474652/

Brain–Computer Interfaces for Treatment of Focal Dystonia Various BCIs have been studied for their potential in the rehabilitation of neurological disorders affecting the sensorimotor system, such as ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04421365

Brain-Computer Interfaces in Laryngeal Dystonia The overall objective of this study is to conduct a randomized, sham-controlled, parallel design, phase 1 clinical trial to assess the feasibility and efficacy ...

3. reporter.nih.gov reporter.nih.gov/project-details/11159412

Adaptive closed-loop brain-computer interface therapeutic ... The overall objective of this study is to conduct a randomized, double-blind, sham- controlled, parallel design, phase 1 clinical trial to assess the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1388245724002360

EEG-based sensorimotor neurofeedback for motor ... This scoping review maps research investigating EEG-based sensorimotor neurofeedback in adults and children with neurological motor impairments, including ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2324242622000080

State-of-the-art non-invasive brain–computer interface for ... BCI has huge potential in the recovery of motor diseases like stroke, spinal cord injury (SCI) and amyotrophic lateral sclerosis (ALS).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11845253/

EEG-based sensorimotor neurofeedback for motor ... Reporting of EEG neurofeedback parameters and outcomes varies widely: greater transparency is required to validate brain-behaviour changes. Keywords: Movement ...

7. mdpi.com mdpi.com/2313-7673/10/8/488

Brain–Computer Interfaces in Parkinson's Disease ... This narrative review explores the clinical potential of BCIs in PD, discussing signal acquisition, processing, and control paradigms.

8. researchgate.net researchgate.net/publication/362611111_Brain-Computer_Interfaces_for_Treatment_of_Focal_Dystonia

Brain–Computer Interfaces for Treatment of Focal Dystonia Task‐specificity in isolated focal dystonias is a powerful feature that may successfully be targeted with therapeutic brain–computer interfaces.