Deep Brain Stimulation for treating laryngeal dystonia

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

This study is testing if Deep Brain Stimulation can help people with Adductor Laryngeal Dystonia improve their vocal function.

Quick facts

• Study type: Observational
• Enrollment: 12 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Indiana University (Academic / other)
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT05506085 on ClinicalTrials.gov

What this trial studies

This study focuses on the use of Deep Brain Stimulation (DBS) to treat Adductor Laryngeal Dystonia (ADLD), a condition affecting vocal cord movement. Participants will undergo specialized testing, including functional MRI and vocal cord imaging, prior to surgery to better understand the mechanisms of dystonia. During the DBS surgery, researchers will monitor brain activity to gain insights into the faulty brain patterns associated with the condition. Post-surgery, participants will have follow-up assessments to evaluate the effectiveness of the DBS in improving their vocal function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 diagnosed with Adductor Laryngeal Dystonia and experiencing tremors.

Not a fit: Patients outside the age range of 18-80 or those with untreated severe mood disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve vocal function and quality of life for patients with laryngeal dystonia.

How similar studies have performed: Other studies have shown promise with Deep Brain Stimulation for various forms of dystonia, indicating potential for success in this novel application.

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 \> 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.

Where this trial is running

Indianapolis, Indiana

• Indiana University — Indianapolis, Indiana, United States (Recruiting)

Study contacts

• Principal investigator: Rita Patel, PhD — Indiana University
• Study coordinator: Rita Patel, PhD

Conditions Laryngeal Dystonia; Adductor Spastic Dysphonia of Dystonia; deep brain stimulation