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Brain-Computer Interface

Brain-Computer Interface for Dystonia

N/A

Recruiting

Led By Kristina Simonyan, MD, PhD

Research Sponsored by Massachusetts Eye and Ear Infirmary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients will have clinically documented isolated adductor laryngeal dystonia (ADLD) without any other forms of dystonia or tremor. ADLD causes involuntary spasms during vocal fold adduction, leading to voice breaks predominantly on vowels and strained, strangles quality of voice, predominantly affecting voice production during the speaking. Only patients with the ADLD form of disorder will be recruited to minimize the impact of heterogeneity of voice symptomatology on the outcome of these phase 1 studies

Healthy controls will be healthy individuals with a negative history of any neurological, psychiatric, or laryngeal problems

Must not have

To avoid the possibility of confounding effects of drugs acting upon the central nervous system, all subjects will be questioned about any prescribed or over-the-counter medications as part of their initial screening. Those who are on medication(s) affecting the central nervous system will be excluded

Subjects with a past or present medical history of (a) neurological problems, such as stroke, movement disorders (except for ADLD in the patient group), brain tumors, ataxias, myopathies, myasthenia gravis, demyelinating diseases; (b) psychiatric problems, such as schizophrenia, bipolar depression, obsessive-compulsive disorder; (c) laryngeal problems, such as vocal fold paralysis, paresis, carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of day 5 of the intervention

Summary

This trial will test a new brain-computer interface therapy for laryngeal dystonia, a condition that causes involuntary muscle contractions in the throat.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this is a non-invasive BCI intervention focusing on feedback from brain activity rather than medication or surgery, traditional side effects may not apply. However, potential discomforts could include fatigue from concentration during sessions or emotional responses due to frustration or challenges while using the BCI.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with isolated adductor laryngeal dystonia affecting my voice.

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I am healthy with no history of brain, mental health, or voice box issues.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medications that affect the brain.

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I have no history of major neurological, psychiatric, or laryngeal problems.

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I am not pregnant or breastfeeding, and my pregnancy test is negative.

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I am capable of understanding and consenting to participate in the study.

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I have not had any brain or throat surgeries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of day 5 of the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of day 5 of the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of day 5 of the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in voice symptoms

Trial Design

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.

0 / 8Eligibility criteria met