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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Brain Stimulation | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | Deep Brain Stimulation of Globus Pallidus interna |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Before surgery, and 6-9 months after surgery |
| Change in Neuropsychological testin: Trails B |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals presenting for routine neurology clinic appointments will be screened for clinical DBS (Deep brain stimulation) candidacy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rita Patel, PhD | Contact | 8128553886 | patelrir@iu.edu | |
| S. Elizabeth Zauber, MD | Contact | 317-963-7437 | szauber@iupui.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rita Patel, PhD | Indiana University | Principal Investigator |
| S. Elizabeth Zauber, MD | Indiana University | Principal Investigator |
| Kunal Gupta, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
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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| ID | Term |
|---|---|
| D055154 | Dysphonia |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Neuropsychological testing will be obtained pre (standard of care for DBS surgery) and 6 months post DBS surgery (experimental) to evaluate mental flexibility |
| 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 | 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) | 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 | 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. | before surgery and 6-9 months after surgery |
| Indiana University |
| Principal Investigator |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |