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Search / Trial NCT05506085

Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application

Launched by INDIANA UNIVERSITY · Aug 16, 2022

Trial Information

Current as of July 12, 2025

Recruiting

Keywords

Deep Brain Stimulation

ClinConnect Summary

This clinical trial is studying a treatment called Deep Brain Stimulation (DBS) for people with a vocal cord condition known as Adductor Laryngeal Dystonia (ADLD). This condition causes difficulty in speaking due to abnormal muscle contractions in the vocal cords. The trial aims to understand how DBS can help improve voice quality for patients suffering from this condition. To participate, individuals must be between 18 and 80 years old, must speak American English, and should not have any other serious neurological issues or recent treatments that could affect their voice.

Participants in the study will first undergo some specialized tests to analyze how their vocal cords move and to gather brain activity data. Then, they will have surgery to implant the DBS device, which helps regulate brain signals that cause the muscle spasms. After the surgery, participants will go through additional voice tests and imaging studies to see how well the treatment is working. This research not only aims to help those with ADLD but also seeks to improve our understanding of how the brain controls voice and speech.

Gender

ALL

Eligibility criteria

  • 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.

About Indiana University

Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.

Locations

Indianapolis, Indiana, United States

Patients applied

0 patients applied

Trial Officials

Rita Patel, PhD

Principal Investigator

Indiana University

S. Elizabeth Zauber, MD

Principal Investigator

Indiana University

Kunal Gupta, MD, PhD

Principal Investigator

Indiana University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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