All > Dystonia

Deep Brain Stimulation for Spasmodic Dysphonia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California San Francisco, San Francisco, CASpasmodic Dysphonia+3 MoreDeep Brain Stimulation - Procedure
Eligibility
18 - 80
All Sexes
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Study Summary

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

Eligible Conditions
  • Spasmodic Dysphonia
  • Tremor
  • Dystonia

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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1
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1
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Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 5 years

5 years
Changes in standard clinical outcome for dystonia patients
Changes in standard clinical outcome for tremor patients
Changes in standard clinical outcome.
Correlations between brain signals and intraoperative voice and speech production performance.

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Brain imaging
1
Isradipine
2
Amifampridine

Side Effects for

Deep Brain Stimulation
23%Fall
15%Depression
8%Restless legs syndrome
8%Apathy
8%Hand fracture
5%Gait disturbance
5%Influenza
5%Head injury
5%Dystonia
5%Speech disorder
5%Tremor
5%Urinary tract infection
5%Dyspepsia
5%Skeletal injury
5%Paraesthesia
5%Back pain
3%Neck pain
3%Axillary pain
3%Diabetes mellitus
3%Implant site haematoma
3%Osteoarthritis
3%Oedema peripheral
3%Pain in extremity
3%Spinal osteoarthritis
3%Adverse drug reaction
3%Cyst
3%Drug withdrawal syndrome
3%Productive cough
3%Parkinson's disease
3%Cystitis
3%Implant site infection
3%Localised infection
3%Pneumonia
3%Staphylococcal infection
3%Device migration
3%Joint sprain
3%Skin laceration
3%Syncope
3%Respiratory depression
3%Fibula fracture
3%Rib fracture
3%Hypoaesthesia
3%Memory impairment
3%Movement disorder
3%Nerve root lesion
3%Sciatica
3%Anger
3%Anxiety
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%Bursitis
3%Intervertebral disc protrusion
3%Monarthritis
3%Fluid retention
3%Folate deficiency
3%Hypertension
3%Hypotension
3%Macular degeneration
3%Laboratory test abnormal
3%Weight increased
3%Pericardial effusion
3%Seborrhoeic keratosis
3%Urinary incontinence
3%Ingrowing nail
3%Akinesia
3%Helicobacter gastritis
3%Alcohol poisoning
3%Thermal burn
3%Cerebral microangiopathy
3%Contusion
3%Dysarthria
3%Postoperative wound infection
3%Arthralgia
3%Cough
3%Pleural effusion
3%Diplopia
3%Pyrexia
3%Thrombophlebitis
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01221948) in the Deep Brain Stimulation ARM group. Side effects include: Fall with 23%, Depression with 15%, Restless legs syndrome with 8%, Apathy with 8%, Hand fracture with 8%.

Trial Design

1 Treatment Group

Electrophysiological signal data collection
1 of 1

Experimental Treatment

120 Total Participants · 1 Treatment Group

Primary Treatment: Deep Brain Stimulation · No Placebo Group · N/A

Electrophysiological signal data collection
Procedure
Experimental Group · 1 Intervention: Deep Brain Stimulation · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~700

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

University of UtahOTHER
1,009 Previous Clinical Trials
1,787,468 Total Patients Enrolled
1 Trials studying Spasmodic Dysphonia
165 Patients Enrolled for Spasmodic Dysphonia
University of California, San FranciscoOTHER
2,312 Previous Clinical Trials
11,758,218 Total Patients Enrolled
3 Trials studying Spasmodic Dysphonia
178 Patients Enrolled for Spasmodic Dysphonia
Massachusetts General HospitalOTHER
2,733 Previous Clinical Trials
31,216,230 Total Patients Enrolled
Massachusetts Eye and Ear InfirmaryLead Sponsor
100 Previous Clinical Trials
12,184 Total Patients Enrolled
2 Trials studying Spasmodic Dysphonia
330 Patients Enrolled for Spasmodic Dysphonia
Kristina Simonyan, MD, PhDPrincipal InvestigatorMassachusetts Eye and Ear
8 Previous Clinical Trials
2,114 Total Patients Enrolled
6 Trials studying Spasmodic Dysphonia
1,074 Patients Enrolled for Spasmodic Dysphonia

Eligibility Criteria

Age 18 - 80 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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