Recruiting

Deep Brain Stimulation

Sponsor:

Indiana University

Code:

NCT05506085

Conditions

Laryngeal Dystonia

Adductor Spastic Dysphonia of Dystonia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation

Study Details

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).

Conditions

Laryngeal Dystonia

Adductor Spastic Dysphonia of Dystonia

Study ID

NCT05506085

Start date

Oct 1, 2022

Status verified date

Aug, 2026

Completion date

Aug 1, 2030

Anticipated

Primary completion date

Aug 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Deep Brain Stimulation

Deep Brain Stimulation of Globus Pallidus interna

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Rita Patel, PhD

8128553886patelrir@iu.edu

S. Elizabeth Zauber, MD

317-963-7437szauber@iupui.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Rita Patel, PhD

812-855-3886patelrir@iu.edu

S. Elizabeth Zauber, MD

317-963-7437szauber@iupui.edu

More Information

Sponsor

Indiana University

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • deep brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-14.