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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will investigate whether or not deep brain stimulation can help improve voice disorders in patients with dystonia or 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.Check my eligibility

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.See study design

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

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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.

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

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

Primary outcome measures

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

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: 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

~700

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor

106 Previous Clinical Trials

12,829 Total Patients Enrolled

2 Trials studying Spasmodic Dysphonia

330 Patients Enrolled for Spasmodic Dysphonia

University of UtahOTHER

1,099 Previous Clinical Trials

1,778,569 Total Patients Enrolled

1 Trials studying Spasmodic Dysphonia

165 Patients Enrolled for Spasmodic Dysphonia

Massachusetts General HospitalOTHER

2,933 Previous Clinical Trials

13,198,361 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

Frequently Asked Questions

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

Does this trial have an age limit, and if so is it younger than fifty-five?

"As per the terms of admission for this trial, participants must be aged between 18 and 80. There is also a subset of 4 trials available to those under 18, as well as 83 more specifically designed for individuals above 65 years old."

Answered by AI

Do I qualify to be a participant in this trial?

"This clinical trial is administering the intervention to 120 patients suffering from tremor, aged 18-80. To be considered for inclusion in this study, applicants must meet the following conditions: have a definite diagnosis of essential tremor or dystonia; demonstrate refractory disease with regards to medication; pass neuropsychological evaluation administered by an accredited clinician; display cognitive aptitude that allows them to understand and complete test directions as well as provide informed consent. Individuals who fail preoperative task training or possess significant hearing loss are excluded from participation, as well those whose cortical venous anatomy might interfere with ECoG electrode placement (as seen on"

Answered by AI

Are there any vacancies available to participate in this research?

"Affirmative, the information accessible through clinicaltrials.gov corroborates that this study is recruiting candidates. It was first announced on June 21st 2022 and its latest update was November 10th of the same year. A total of 120 individuals are required to be recruited from 4 sites."

Answered by AI

How many individuals are being observed in this research project?

"Indeed, the clinical trial is actively seeking participants. On June 21st 2022 it was initially posted and edited most recently on November 10th 2022. 120 individuals are expected to be recruited from 4 distinct medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

Kristina Simonyan 2022. "Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05150093.

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