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Neurosurgical Procedure

Deep Brain Stimulation for Spasmodic Dysphonia

N/A

Recruiting

Led By S. Elizabeth Zauber, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before surgery, within 24 hours after surgery, 6-9 months after surgery

Awards & highlights

Study Summary

This trial will enroll people with Adductor Laryngeal Dystonia (ADLD) to study the efficacy of Deep Brain Stimulation (DBS) in treating the condition. DBS is a neurosurgical procedure used to treat tremors and dystonia. Before surgery, participants will undergo specialized testing to study the movement of the vocal cords, as well as functional MRI. In the operating room, researchers will examine brain waves to better understand how faulty brain firing patterns lead to dystonia. After surgery, participants will repeat speech testing and vocal cord imaging as well as MRI.

Eligible Conditions

Spasmodic Dysphonia
Adductor Spastic Dysphonia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before surgery, within 24 hours after surgery, 6 -9 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before surgery, within 24 hours after surgery, 6 -9 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and before surgery, within 24 hours after surgery, 6 -9 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Acoustic voice recordings

Change in total number of Vocal fold movements

Microelectrode recording

Secondary outcome measures

Change in Neuropsychological testin: Trails B

Change in Neuropsychological testing: Controlled Oral Word Association Animal fluency

Change in Neuropsychological testing: Trails A

+3 more

Side effects data

From 2018 Phase 2 trial • 53 Patients • NCT01221948

23%

Fall

15%

Depression

Hand fracture

Restless legs syndrome

Apathy

Head injury

Dyspepsia

Back pain

Speech disorder

Skeletal injury

Tremor

Gait disturbance

Dystonia

Paraesthesia

Influenza

Urinary tract infection

Pain in extremity

Diabetes mellitus

Intervertebral disc protrusion

Spinal osteoarthritis

Fluid retention

Postoperative wound infection

Osteoarthritis

Macular degeneration

Hypoaesthesia

Ingrowing nail

Respiratory depression

Parkinson's disease

Akinesia

Productive cough

Device migration

Syncope

Diplopia

Skin laceration

Joint sprain

Rib fracture

Drug withdrawal syndrome

Alcohol poisoning

Contusion

Cerebral microangiopathy

Dysarthria

Memory impairment

Movement disorder

Monarthritis

Neck pain

Adverse drug reaction

Cyst

Implant site haematoma

Oedema peripheral

Pyrexia

Pleural effusion

Nerve root lesion

Anxiety

Cough

Fibula fracture

Thermal burn

Sciatica

Anger

Bursitis

Cystitis

Helicobacter gastritis

Implant site infection

Localised infection

Pneumonia

Staphylococcal infection

Confusional state

Depressed mood

Hallucination, auditory

Impulse-control disorder

Insomnia

Panic attack

Rapid eye movements sleep abnormal

Bronchitis

Ear infection

Incision site infection

Arthralgia

Axillary pain

Folate deficiency

Hypertension

Hypotension

Thrombophlebitis

Laboratory test abnormal

Weight increased

Pericardial effusion

Seborrhoeic keratosis

Urinary incontinence

100%

80%

60%

40%

20%

Study treatment Arm

Deep Brain Stimulation

Trial Design

1Treatment groups

Experimental Treatment

Group I: Deep Brain StimulationExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deep Brain Stimulation

2011

Completed Phase 2

~700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,289 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,698 Previous Clinical Trials

7,492,487 Total Patients Enrolled

1 Trials studying Spasmodic Dysphonia

53 Patients Enrolled for Spasmodic Dysphonia

S. Elizabeth Zauber, MDPrincipal InvestigatorIndiana University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is allowed to join in this medical experiment?

"Eligibility for this clinical trial requires adductor spastic dysphonia of dystonia and an age range between 18 to 70. This research study is striving to recruit 12 participants in total."

Answered by AI

Are individuals aged 55 or above able to partake in this research?

"This medical trial has an age criteria of 18 to 70 years old, and is thus open for enrolment by those that meet this requirement."

Answered by AI

Are there any unfilled positions for participants in this experiment?

"At present, clinicaltrials.gov reports that this trial is not recruiting patients, as the post dated 9th September 2022 has been last updated on 16th August 2022. Nevertheless, 48 other trials are currently in search of participants at this time."

Answered by AI

What are the primary aims of this medical experiment?

"The primary aim of this experiment, tested before and after surgery over a 6-month period, is to measure changes in acoustic voice recordings. Secondary metrics include fluctuations on Neuropsychological testing Trails B (mental flexibility), Trails A (psychomotor speed) and the Voice Handicap Index - an indicator ranging from 0 to 120 which determines patients' vocal handicap severity."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Rita R. Patel 2022. "Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05506085.