RECRUITING

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

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Conditions

Laryngeal DystoniaAdductor Spastic Dysphonia of Dystoniadeep brain stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-10-01
Study Completion:2025-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05506085

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with ADLD and ADLD plus tremor, as diagnosed by routine clinical examination by laryngologist, speech language pathologist, and neurologist.
  2. * Patients undergoing globus pallidus interna (GPi) deep brain stimulation (DBS) for ADLD with tremor
  3. * Age range of 18-80 years
  4. * Native speakers of American English will be recruited since there are known differences in voice and neural signals of native and non-native speakers
  5. * No evidence for dementia as assessed by neurologist.
  6. * 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.
  7. * 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.
  1. * Individuals younger than 18 years and older than 80 years of age.
  2. * Women who plan to become pregnant during the study period or are currently breastfeeding.
  3. * Prior history of stroke, brain surgery, or other neurological disorder besides the one under study.
  4. * Prior laryngeal framework surgeries or other disorders affecting the vocal folds
  5. * Patients who are asymptomatic due to treatment with botulinum toxin into the vocal folds.
  6. * Presence of ferromagnetic implants and cardiac implants that would be contraindicated to MRI
  7. * Gagging or discomfort that would preclude the placement of the endoscope to visualize the larynx
  8. * Dementia, severe depression or severe anxiety.
  9. * Any clinical condition or medication judged by the investigators to potentially preclude the patient from safely completing awake brain surgery and research protocols.

Contacts and Locations

Study Contact

Rita Patel, PhD
CONTACT
8128553886
patelrir@iu.edu
S. Elizabeth Zauber, MD
CONTACT
317-963-7437
szauber@iupui.edu

Principal Investigator

Rita Patel, PhD
PRINCIPAL_INVESTIGATOR
Indiana University
S. Elizabeth Zauber, MD
PRINCIPAL_INVESTIGATOR
Indiana University
Kunal Gupta, MD, PhD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Indiana University
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Rita Patel, PhD, PRINCIPAL_INVESTIGATOR, Indiana University
  • S. Elizabeth Zauber, MD, PRINCIPAL_INVESTIGATOR, Indiana University
  • Kunal Gupta, MD, PhD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2025-05-01

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2025-05-01

Terms related to this study

Keywords Provided by Researchers

  • deep brain stimulation

Additional Relevant MeSH Terms

  • Laryngeal Dystonia
  • Adductor Spastic Dysphonia of Dystonia