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NCT Number: NCT05506085

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

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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Key information

Conditions

Laryngeal Dystonia Adductor Spastic Dysphonia of Dystonia Dysphonia Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Voice Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Amol Yadav, PhD

SUB_INVESTIGATOR

David Kareken, PhD

SUB_INVESTIGATOR

Rita Patel, PhD

CONTACT

[email protected]

812-855-3886

S. Elizabeth Zauber, MD

CONTACT

[email protected]

317-963-7437

Stacey Halum, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deep brain stimulation

Device

Deep Brain Stimulation of Globus Pallidus interna

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in Neuropsychological testing: Trails A

    Time frame: Before surgery, and 6-9 months after surgery

    Neuropsychological testing will be obtained pre (standard of care for DBS surgery) and 6 months post DBS surgery (experimental) to evaluate psychomotor speed

  2. Change in Neuropsychological testin: Trails B

    Time frame: Before surgery, and 6-9 months after surgery

    Neuropsychological testing will be obtained pre (standard of care for DBS surgery) and 6 months post DBS surgery (experimental) to evaluate mental flexibility

  3. Change in Neuropsychological testing: Controlled Oral Word Association Animal fluency

    Time frame: Before surgery, and 6-9 months after surgery

    Neuropsychological testing will be obtained pre (standard of care for DBS surgery) and 6-9 months post DBS surgery (experimental) to evaluate verbal fluency

  4. Change in Resting state Functional Magnetic Resonance Imaging (fMRI)

    Time frame: before surgery and 6-9 months after surgery

    Resting state Functional Magnetic Resonance Imaging (rs-FMRI)

  5. Change in Voice Handicap Index

    Time frame: before surgery and 6-9 months after surgery

    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

  6. Change in Speech Intelligibility

    Time frame: before surgery and 6-9 months after surgery

    will be computed from the 2nd, 3rd, and 4th sentences of the Rainbow passage as the number of correct words identified.

Study contacts

Contact information is provided by the study sponsor or research team.

Rita Patel, PhD

CONTACT

[email protected]

8128553886

S. Elizabeth Zauber, MD

CONTACT

[email protected]

317-963-7437

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Aug 18, 2022
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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