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Procedure

Deep Brain Stimulation for Spasmodic Dysphonia and Tremor

N/A
Recruiting
Led By Kristina Simonyan, MD, PhD
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80 years.
Clinical indications to proceed with DBS implantation, as determined by the clinical multidisciplinary movement disorders board, including definitive diagnosis of essential tremor or dystonia, medically refractory disease, and adequate performance on neuropsychological evaluation as determined by a licensed clinical neuropsychologist.
Must not have
Significant hearing loss.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how Deep Brain Stimulation (DBS) affects voice control in patients with dystonia and essential tremor. DBS sends electrical impulses to brain areas that manage movement, aiming to improve voice function in these patients. Deep Brain Stimulation (DBS) has been used to treat severe movement disorders, including Parkinson's disease, dystonia, and essential tremor.

Who is the study for?
This trial is for adults aged 18-80 with voice disorders due to dystonia or essential tremor, who are candidates for deep brain stimulation (DBS) surgery. Participants must be able to follow instructions, complete training, and give informed consent. They should not have obstructive venous anatomy, significant hearing loss, or inability to perform required tasks.
What is being tested?
The study aims to understand how often voice disorders occur in patients with dystonia and essential tremor treated with DBS. It will explore the changes in brain imaging and activity related to voice dysfunction before and after the treatment.
What are the potential side effects?
While specific side effects of DBS on voice functions aren't detailed here, common risks include speech problems, muscle stiffness or numbness around the implant site, headache, balance issues, mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old.
Select...
I am approved for DBS surgery for my essential tremor or dystonia by a specialist team.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have significant hearing loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in standard clinical outcome for dystonia patients
Changes in standard clinical outcome for tremor patients
Correlations between brain signals and intraoperative voice and speech production performance.

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%
Ingrowing nail
3%
Osteoarthritis
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: Electrophysiological signal data collectionExperimental Treatment1 Intervention
Patients diagnosed with dystonia or tremor who are recommended for DBS surgery. Electrophysiological data will be collected at the time of DBS surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~710

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Spasmodic Dysphonia (SD) treatments like Botulinum toxin (Botox) injections and Deep Brain Stimulation (DBS) focus on reducing involuntary vocal cord spasms. Botox temporarily paralyzes the affected muscles, improving voice quality by reducing spasms. DBS involves implanting electrodes to modulate abnormal brain signals, normalizing neural activity and reducing symptoms. These treatments are significant for SD patients as they target the root neural dysfunctions, offering symptom relief and enhancing quality of life.

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor
108 Previous Clinical Trials
12,914 Total Patients Enrolled
2 Trials studying Spasmodic Dysphonia
330 Patients Enrolled for Spasmodic Dysphonia
University of UtahOTHER
1,136 Previous Clinical Trials
1,791,185 Total Patients Enrolled
1 Trials studying Spasmodic Dysphonia
165 Patients Enrolled for Spasmodic Dysphonia
Massachusetts General HospitalOTHER
3,006 Previous Clinical Trials
13,307,162 Total Patients Enrolled

Media Library

Deep Brain Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05150093 — N/A
Spasmodic Dysphonia Research Study Groups: Electrophysiological signal data collection
Spasmodic Dysphonia Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT05150093 — N/A
Deep Brain Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05150093 — N/A
~53 spots leftby Aug 2026