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Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Spasmodic Dysphonia
Laryngeal Dystonia

Treatments

Device: Vibro-tactile stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06111027
STUDY00019659

Details and patient eligibility

About

The general aim of the study is to provide evidence for usability and feasibility of applying vibro-tactile stimulation (VTS) at home as a non-invasive form of neuromodulation to improve speech in people with spasmodic dysphonia (SD). This work addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with very limited treatment options. Successful completion of the proposed work will be an important step in advancing laryngeal VTS as a therapeutic intervention for improving voice symptoms in SD.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of spasmodic dysphonia (laryngeal dystonia) for a minimum of 6 months with documented symptom relief after Botox injection.
  • Diagnosis is made by a voice disorder specialist.

Exclusion criteria

  • Regular intake of benzodiazepines
  • Cognitive impairment: score < 27 on Mini-mental state examination
  • Identifies with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Intervention
Experimental group
Description:
Will use the device, single group
Treatment:
Device: Vibro-tactile stimulation

Trial contacts and locations

1

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Central trial contact

Cagla Ozkul

Data sourced from clinicaltrials.gov

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