What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Spasmodic Dysphonia include botulinum toxin injections and neuromodulation techniques such as Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS). Botulinum toxin injections can cause side effects like breathiness, swallowing difficulties, and hoarseness. DBS, while generally safe, may lead to complications such as infection, bleeding, or hardware-related issues. TMS is associated with mild side effects like scalp discomfort, headaches, and in rare cases, seizures. These treatments aim to modulate brain activity to improve voice function.

What prior FDA approvals exist?

The FDA has approved botulinum toxin injections as a primary treatment for Spasmodic Dysphonia, which works by temporarily paralyzing the muscles causing the voice spasms. While Deep Brain Stimulation (DBS) is being studied for its potential in treating neurological voice disorders, including Spasmodic Dysphonia, it is not yet FDA-approved specifically for this condition. DBS is approved for other movement disorders like Parkinson's disease and essential tremor, indicating its potential applicability in modulating brain activity for voice disorders.

What other types of research exist?

Promising novel alternatives to Deep Brain Stimulation for Spasmodic Dysphonia patients include: 1) Botulinum toxin injections, which have been effective in treating dystonic tremor of the head and essential voice tremor. 2) Transcutaneous electrical nerve stimulation (TENS), which has shown benefits in other neurological conditions and may be adapted for voice disorders. 3) Transcranial magnetic stimulation (TMS), which has been effective in other movement disorders and may offer a non-invasive option for modulating brain activity.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Hand fracture

Restless legs syndrome

Apathy

Dyspepsia

Back pain

Skeletal injury

Head injury

Speech disorder

Tremor

Gait disturbance

Dystonia

Paraesthesia

Influenza

Urinary tract infection

Osteoarthritis

Ingrowing nail

Postoperative wound infection

Diabetes mellitus

Pain in extremity

Spinal osteoarthritis

Alcohol poisoning

Intervertebral disc protrusion

Hypoaesthesia

Diplopia

Contusion

Productive cough

Joint sprain

Macular degeneration

Fluid retention

Device migration

Skin laceration

Akinesia

Parkinson's disease

Syncope

Respiratory depression

Rib fracture

Drug withdrawal syndrome

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

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

0 / 3Eligibility criteria met

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.