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

Last updated: June 6, 2024
Sponsor: Indiana University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dystonias

Dyskinesias

Dystonia

Treatment

Deep Brain Stimulation

Clinical Study ID

NCT05506085
14578
  • Ages 18-70
  • All Genders

Study Summary

Deep Brain Stimulation (DBS) is a neurosurgical procedure used to treat tremors, and dystonia. This study will enroll people who have a form of focal dystonia that affects their vocal cords called Adductor Laryngeal dystonia (ADLD). Participants will undergo Deep Brain Stimulation surgery to treat laryngeal dystonia as part of their clinical care. Before surgery, as part of the study they will have specialized testing to study the movement of the vocal cords, as well as functional magnetic resonance imaging (fMRI). While in the operating room, researchers will examine brain waves to better understand how faulty brain firing patterns lead to dystonia. After surgery, and activation of the deep brain stimulator, participants will repeat speech testing and vocal cord imaging as well as magnetic resonance imaging (MRI).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with ADLD and ADLD plus tremor, as diagnosed by routine clinicalexamination by laryngologist, speech language pathologist, and neurologist.

  • Patients undergoing globus pallidus interna (GPi) deep brain stimulation (DBS) forADLD with tremor

  • Age range of 18-80 years

  • Native speakers of American English will be recruited since there are knowndifferences 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 asevident on self-report (Beck Depression Inventory-II score > 29, Beck AnxietyInventory Score > 26.

  • At least 3 months since last botulinum toxin injection and the patients would needto be fully symptomatic with no residual effects of botulinum toxin on voicequality.

Exclusion

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 currentlybreastfeeding.

  • Prior history of stroke, brain surgery, or other neurological disorder besides theone 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 vocalfolds.

  • Presence of ferromagnetic implants and cardiac implants that would becontraindicated to MRI

  • Gagging or discomfort that would preclude the placement of the endoscope tovisualize the larynx

  • Dementia, severe depression or severe anxiety.

  • Any clinical condition or medication judged by the investigators to potentiallypreclude the patient from safely completing awake brain surgery and researchprotocols.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Deep Brain Stimulation
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
May 01, 2025

Connect with a study center

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

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