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Recruiting NCT05506085

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

— Observational Laryngeal Dystonia Adductor Spastic Dysphonia of Dystonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Brain Stimulation.
Who it may be relevant to
Registry conditions: Laryngeal Dystonia, Adductor Spastic Dysphonia of Dystonia. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

  • Device Deep Brain Stimulation
    Deep Brain Stimulation of Globus Pallidus interna

Primary outcome measures

  • Change in total number of Vocal fold movements [Time frame: Before surgery, within 24 hours after surgery, 6 -9 months after surgery]
  • Change in Acoustic voice recordings [Time frame: Before surgery, within 24 hours after surgery, 6-9 months after surgery]
  • Microelectrode recording [Time frame: during surgery]
Secondary outcome measures (6)
  • Change in Neuropsychological testing: Trails A [Time frame: Before surgery, and 6-9 months after surgery]
  • Change in Neuropsychological testin: Trails B [Time frame: Before surgery, and 6-9 months after surgery]
  • Change in Neuropsychological testing: Controlled Oral Word Association Animal fluency [Time frame: Before surgery, and 6-9 months after surgery]
  • Change in Resting state Functional Magnetic Resonance Imaging (fMRI) [Time frame: before surgery and 6-9 months after surgery]
  • Change in Voice Handicap Index [Time frame: before surgery and 6-9 months after surgery]
  • Change in Speech Intelligibility [Time frame: before surgery and 6-9 months after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Indiana University — Indianapolis

Identifiers

NCT: NCT05506085 · 14578

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗