Deep Brain Stimulation for treating laryngeal dystonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on the use of Deep Brain Stimulation (DBS) to treat Adductor Laryngeal Dystonia (ADLD), a condition affecting vocal cord movement. Participants will undergo specialized testing, including functional MRI and vocal cord imaging, prior to surgery to better understand the mechanisms of dystonia. During the DBS surgery, researchers will monitor brain activity to gain insights into the faulty brain patterns associated with the condition. Post-surgery, participants will have follow-up assessments to evaluate the effectiveness of the DBS in improving their vocal function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with ADLD and ADLD plus tremor, as diagnosed by routine clinical examination by laryngologist, speech language pathologist, and neurologist.
* Patients undergoing globus pallidus interna (GPi) deep brain stimulation (DBS) for ADLD with tremor
* Age range of 18-80 years
* Native speakers of American English will be recruited since there are known differences in voice and neural signals of native and non-native speakers
* No evidence for dementia as assessed by neurologist.
* No evidence for severe untreated mood disorder as assessed by neurologist, or as evident on self-report (Beck Depression Inventory-II score \> 29, Beck Anxiety Inventory Score \> 26.
* At least 3 months since last botulinum toxin injection and the patients would need to be fully symptomatic with no residual effects of botulinum toxin on voice quality.

Exclusion Criteria:

* Individuals younger than 18 years and older than 80 years of age.
* Women who plan to become pregnant during the study period or are currently breastfeeding.
* Prior history of stroke, brain surgery, or other neurological disorder besides the one under study.
* Prior laryngeal framework surgeries or other disorders affecting the vocal folds
* Patients who are asymptomatic due to treatment with botulinum toxin into the vocal folds.
* Presence of ferromagnetic implants and cardiac implants that would be contraindicated to MRI
* Gagging or discomfort that would preclude the placement of the endoscope to visualize the larynx
* Dementia, severe depression or severe anxiety.
* Any clinical condition or medication judged by the investigators to potentially preclude the patient from safely completing awake brain surgery and research protocols.

Where it's running

• Indiana University
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Rita Patel, PhD — Indiana University
• Study coordinator: Rita Patel, PhD
• Email: patelrir@iu.edu
• Phone: 8128553886

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How gentle vibration to the throat affects brain activity in people with laryngeal dystonia

  This study will test whether a short session of noninvasive vibro-tactile stimulation to the larynx can improve voice symptoms and alter brain network activity in adults with laryngeal dystonia.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT07443891

• Transcranial direct current stimulation for laryngeal dystonia

  This trial will try transcranial direct current stimulation (tDCS) in people with laryngeal dystonia to see if it improves voice control.

  Recruiting Yale University · New Haven, Connecticut · NCT06830174

• Examining brain function in laryngeal dystonia and voice tremor

  This study is testing how brain function differs in people with laryngeal dystonia and voice tremor compared to healthy individuals to better understand these voice disorders.

  Recruiting Early Phase 1 Massachusetts Eye and Ear Infirmary · Boston, Massachusetts · NCT05216770

• Evaluating voice disorders like laryngeal dystonia and voice tremor

  This study is testing new ways to tell the difference between laryngeal dystonia and voice tremor to help people get the right treatment for their voice disorders.

  Recruiting Massachusetts Eye and Ear Infirmary · Boston, Massachusetts · NCT05150106

• Deep Brain Stimulation for Voice Disorders in Dystonia and Tremor

  This study is testing if deep brain stimulation can improve voice problems in people with laryngeal dystonia and essential tremor.

  Recruiting Massachusetts Eye and Ear Infirmary · Boston, Massachusetts · NCT05150093

• Neuromodulation effects on laryngeal dystonia

  This study is testing if a brain stimulation treatment can help people with laryngeal dystonia improve their voice and overall quality of life.

  Recruiting MGH Institute of Health Professions · Boston, Massachusetts · NCT05095740

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.