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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
No Placebo-Only Group

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Acoustic voice recordings
Change in total number of Vocal fold movements
Microelectrode recording
Secondary study objectives
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
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Dyspepsia
5%
Back pain
5%
Skeletal injury
5%
Head injury
5%
Speech disorder
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Osteoarthritis
3%
Ingrowing nail
3%
Postoperative wound infection
3%
Diabetes mellitus
3%
Pain in extremity
3%
Spinal osteoarthritis
3%
Alcohol poisoning
3%
Intervertebral disc protrusion
3%
Hypoaesthesia
3%
Diplopia
3%
Contusion
3%
Productive cough
3%
Joint sprain
3%
Macular degeneration
3%
Fluid retention
3%
Device migration
3%
Skin laceration
3%
Akinesia
3%
Parkinson's disease
3%
Syncope
3%
Respiratory depression
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Cerebral microangiopathy
3%
Dysarthria
3%
Memory impairment
3%
Movement disorder
3%
Monarthritis
3%
Neck pain
3%
Adverse drug reaction
3%
Cyst
3%
Implant site haematoma
3%
Oedema peripheral
3%
Pyrexia
3%
Pleural effusion
3%
Nerve root lesion
3%
Anxiety
3%
Cough
3%
Fibula fracture
3%
Thermal burn
3%
Sciatica
3%
Anger
3%
Bursitis
3%
Cystitis
3%
Helicobacter gastritis
3%
Implant site infection
3%
Localised infection
3%
Pneumonia
3%
Staphylococcal infection
3%
Confusional state
3%
Depressed mood
3%
Hallucination, auditory
3%
Impulse-control disorder
3%
Insomnia
3%
Panic attack
3%
Rapid eye movements sleep abnormal
3%
Bronchitis
3%
Ear infection
3%
Incision site infection
3%
Arthralgia
3%
Axillary pain
3%
Folate deficiency
3%
Hypertension
3%
Hypotension
3%
Thrombophlebitis
3%
Laboratory test abnormal
3%
Weight increased
3%
Pericardial effusion
3%
Seborrhoeic keratosis
3%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Deep Brain Stimulation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~710

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,039 Previous Clinical Trials
1,219,046 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,819 Previous Clinical Trials
8,162,071 Total Patients Enrolled
1 Trials studying Spasmodic Dysphonia
53 Patients Enrolled for Spasmodic Dysphonia
S. Elizabeth Zauber, MDPrincipal InvestigatorIndiana University
~2 spots leftby May 2025
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