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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of day 5 of the intervention
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with isolated adductor laryngeal dystonia affecting my voice.
Select...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
106 Previous Clinical Trials
12,909 Total Patients Enrolled
3 Trials studying Spasmodic Dysphonia
450 Patients Enrolled for Spasmodic Dysphonia
Kristina Simonyan, MD, PhDPrincipal InvestigatorMassachusetts Eye and Ear
8 Previous Clinical Trials
2,194 Total Patients Enrolled
6 Trials studying Spasmodic Dysphonia
784 Patients Enrolled for Spasmodic Dysphonia
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Sham neurofeedback BCI
- Group 2: Active neurofeedback BCI
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is eligibility for this experiment extended?
"This medical study is seeking forty individuals over the age of eighteen and under eighty with focal dystonia. Criteria for enrolment includes clinically documented isolated adductor laryngeal dystonia (ADLD) without any other forms of tremor or movement disorder, right-handedness as determined by Edinburgh Handedness Inventory, no history of neurological, psychiatric, or laryngeal issues amongst control subjects; and an appropriate age range between 18 to 80 years old."
Answered by AI
Does this medical trial accept elderly participants?
"This medical trial is available to those aged 18 and over, but no older than 80."
Answered by AI
Are researchers presently recruiting participants for this experiment?
"Indeed, this clinical trial is open for enrollment and the information hosted on clinicaltrials.gov was last modified on August 10th 2022. The original announcement of the study was issued on April 18th 2022."
Answered by AI
What is the current enrollment tally for this clinical trial?
"Affirmative. The clinical trial portal, which was first posted on April 18th 2022, confirms that this research is actively seeking participants. This study will enlist 40 individuals from one site."
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