Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorIndiana University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Individuals presenting for routine neurology clinic appointments will be screened for clinical DBS (Deep brain stimulation) candidacy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Deep Brain Stimulation
DeviceDeep Brain Stimulation of Globus Pallidus interna
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Deep Brain Stimulation1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Before surgery, within 24 hours after surgery, 6 -9 months after surgery2
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.
Time frame
Before surgery, within 24 hours after surgery, 6-9 months after surgery3
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.
Time frame
during surgerySecondary outcomes
1
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
Time frame
Before surgery, and 6-9 months after surgery2
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
Time frame
Before surgery, and 6-9 months after surgery3
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
Time frame
Before surgery, and 6-9 months after surgery4
Change in Resting state Functional Magnetic Resonance Imaging (fMRI)
Resting state Functional Magnetic Resonance Imaging (rs-FMRI)
Time frame
before surgery and 6-9 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov