An observational study in Laryngeal Dystonia and Adductor Spastic Dysphonia of Dystonia, sponsored by Indiana University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Indiana University · Observational
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).
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's planned enrollment of 12 is below the median of 123 across 40 observational studies indexed under Dysphonia.
Browse Dysphonia studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
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Individuals presenting for routine neurology clinic appointments will be screened for clinical DBS (Deep brain stimulation) candidacy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Voice outcomes and Magnetic resonance imaging will be compared pre- and post-DBS (Deep brain stimulation) in patients with laryngeal dystonia and adductor laryngeal dystonia. The evaluators will be masked for analyzing the voice outcomes pre-and post-DBS
Device: Deep Brain Stimulation
Deep Brain Stimulation of Globus Pallidus interna
Change in total number of Vocal fold movements
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
Time frame: Before surgery, within 24 hours after surgery, 6 -9 months after surgery
Change in Acoustic voice recordings
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.
Time frame: Before surgery, within 24 hours after surgery, 6-9 months after surgery
Microelectrode recording
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.
Time frame: during surgery
Change in Neuropsychological testing: Trails A
Neuropsychological testing will be obtained pre (standard of care for DBS surgery) and 6 months post DBS surgery (experimental) to evaluate psychomotor speed
Time frame: Before surgery, and 6-9 months after surgery
Change in Neuropsychological testin: Trails B
Neuropsychological testing will be obtained pre (standard of care for DBS surgery) and 6 months post DBS surgery (experimental) to evaluate mental flexibility
Time frame: Before surgery, and 6-9 months after surgery
Change in Neuropsychological testing: Controlled Oral Word Association Animal fluency
Neuropsychological testing will be obtained pre (standard of care for DBS surgery) and 6-9 months post DBS surgery (experimental) to evaluate verbal fluency
Time frame: Before surgery, and 6-9 months after surgery
Change in Resting state Functional Magnetic Resonance Imaging (fMRI)
Resting state Functional Magnetic Resonance Imaging (rs-FMRI)
Time frame: before surgery and 6-9 months after surgery
Change in Voice Handicap Index
A 30-point questionnaire to describe the voice and the effects of voice on their daily lives. The scores range from 0 to 120. 0 to 30 is a low score with minimal handicap and 61 to 120 is considered severe handicap, 31 to 60 moderate handicap
Time frame: before surgery and 6-9 months after surgery
Change in Speech Intelligibility
will be computed from the 2nd, 3rd, and 4th sentences of the Rainbow passage as the number of correct words identified.
Time frame: before surgery and 6-9 months after surgery
Plan to share: Undecided — De-identified data from individual patient data (IPD) will be made available to other researchers on request. We also plan to post IPD after study completion on IUScholarWorks where other researchers could access it.
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