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

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. ^{1 2 3 4 5}

Is 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. ^{1 3 6 7 8}

How 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. ^{1 2 3 4 9}

Research Team

Kristina Simonyan, MD, PhD

Principal Investigator

Massachusetts Eye and Ear

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Functional recovery from chronic writer's cramp by brain-computer interface rehabilitation: a case report. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment effectiveness of brain-computer interface training for patients with focal hand dystonia: A double-case study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

EMG-based visual-haptic biofeedback: a tool to improve motor control in children with primary dystonia. [2013]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Chronic deep brain stimulation normalizes scalp EEG activity in isolated dystonia. [2019]

5. Netherlands 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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. [2015]

7. Switzerland 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. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A multicenter effectiveness trial of QEEG-informed neurofeedback in ADHD: Replication and treatment prediction. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Single-trial classification of feedback potentials within neurofeedback training with an EEG brain-computer interface. [2020]