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Clinical Trials/NCT05506085
NCT05506085
Recruiting
N/A

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

Indiana University1 site in 1 country12 target enrollmentOctober 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Laryngeal Dystonia
Sponsor
Indiana University
Enrollment
12
Locations
1
Primary Endpoint
Change in total number of Vocal fold movements
Status
Recruiting
Last Updated
9 months ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
August 1, 2030
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rita R. Patel

Associate Professor, Speech & Hearing Sciences

Indiana University

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 \>
  • 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.

Outcomes

Primary Outcomes

Change in total number of Vocal fold movements

Time Frame: Before surgery, within 24 hours after surgery, 6 -9 months after surgery

Vocal fold movements will be quantified (vibratory breaks + micromotions+ aperiodicities) using high-speed videoendoscopy (HSV) on sustained phonation of the vowel, words, and sentence production. The videoendoscopic recording will be obtained

Change in Acoustic voice recordings

Time Frame: Before surgery, within 24 hours after surgery, 6-9 months after surgery

Acoustic voice recordings will be obtained using a microphone. Acoustic measurement of voice (voicing percentage) will be obtained from sustained phonation of the vowel /a/, sentences and reading a paragraph.

Microelectrode recording

Time Frame: during surgery

Microelectrode recording is performed routinely during DBS (Deep brain stimulation) surgery. The study procedure will be to record voice simultaneously on sustained phonation of the vowels, syllables, and sentences using the data acquisition system NI USM 6221 with a microphone and high-speed videoendoscopy. Beta and theta band power spectral density will be analyzed as measurements.

Secondary Outcomes

  • Change in Neuropsychological testing: Trails A(Before surgery, and 6-9 months after surgery)
  • Change in Voice Handicap Index(before surgery and 6-9 months after surgery)
  • Change in Speech Intelligibility(before surgery and 6-9 months after surgery)
  • Change in Neuropsychological testin: Trails B(Before surgery, and 6-9 months after surgery)
  • Change in Neuropsychological testing: Controlled Oral Word Association Animal fluency(Before surgery, and 6-9 months after surgery)
  • Change in Resting state Functional Magnetic Resonance Imaging (fMRI)(before surgery and 6-9 months after surgery)

Study Sites (1)

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