Laryngeal DystoniaNCT05506085
Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
An observational study of Laryngeal Dystonia and Adductor Spastic Dysphonia of Dystonia, run by Indiana University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laryngeal Dystonia, Adductor Spastic Dysphonia of Dystonia
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals presenting for routine neurology clinic appointments will be screened for clinical DBS (Deep brain stimulation) candidacy
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Rita Patel, PhD, 812-855-3886, patelrir@iu.edu
S. Elizabeth Zauber, MD, 317-963-7437, szauber@iupui.edu
About this study
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).
- Being tested
- Deep Brain Stimulation
- Keywords
- deep brain stimulation
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Deep Brain Stimulation of Globus Pallidus interna
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: during surgery
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: before surgery and 6-9 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Oct 2022
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal DystoniaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Rita R. Patel, Indiana University
- Investigators
- Rita Patel, PhD, Principal investigator, Indiana UniversityS. Elizabeth Zauber, MD, Principal investigator, Indiana UniversityKunal Gupta, MD, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506085
- Sponsor's protocol ID
- 14578
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
- ClinicalTrials.gov ID
- NCT05506085
- Acronym / sponsor ID
- 14578
- Keywords
- deep brain stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | – | Device: Deep Brain StimulationVoice 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals presenting for routine neurology clinic appointments will be screened for clinical DBS (Deep brain stimulation) candidacy
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationDeep Brain Stimulation of Globus Pallidus interna | Device | Deep Brain Stimulation |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: 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.
Related trials for Laryngeal Dystonia
Not yet recruiting
EMG-Guided Versus Endoscopic-Catheter Botulinum Toxin Injection for Spasmodic Dysphonia
Spasmodic Dysphonia
Not yet recruiting
Transcranial Magnetic Stimulation in Laryngeal Dystonia
Laryngeal Dystonia, Spasmodic Dysphonia
Not yet recruitingPhase 1
Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor
Spasmodic Dysphonia, Laryngeal Dystonia
Recruiting
Brain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia
Laryngeal Dystonia
Recruiting
Effects of Neuromodulation in Laryngeal Dystonia
Laryngeal Dystonia, Focal Dystonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rita Patel, PhD principal investigator
Indiana University
S. Elizabeth Zauber, MD principal investigator
Indiana University
Kunal Gupta, MD, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Dystonia and Adductor Spastic Dysphonia of Dystonia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rita Patel, PhD (8128553886, patelrir@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total number of Vocal fold movements (time frame: Before surgery, within 24 hours after surgery, 6 -9 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.