Stimulation of the Thalamus to Ameliorate Persistent Disfluency

NCT05641701 | Unknown DMC

• 1 other identifier: H22-02984
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

Persistent developmental stutter / childhood onset fluency disorder is a disabling condition leading to significant communication and psychological disability. Established treatment consists of intensive speech therapy, and whilst initially effective, has a waning long-term benefit. Our research team aims to provide evidence of stutter management by addressing the primary neurological issue in this disorder using Deep Brain Stimulation. The investigators propose to perform bilateral DBS on 3 participants with stutter refractory to intensive speech therapy, to determine a response in their stutter. The assessments will be double-blinded. The investigators will use the outcome of this small pilot study to determine the feasibility and details of a larger randomized controlled trial.

Conditions

Persistent Developmental Stutter; Childhood-Onset Fluency Disorder (Stuttering)

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Change of One-Page Suttering Assessment from Baseline to Post-Operation

  Objectively assesses individual's stutter. Divide the number of instances of stuttering by the number of syllables in the sample and multiply by 100 to obtain the percentage of stuttered syllables.

  Baseline assessment will be done pre-operatively. Four weeks after device programming, the patients will attend the DBS clinic for 1-page stutter assessment with bilateral electrodes on.

Secondary Outcomes (2)

• Change of Voice Related Quality of Life (VRQoL) from Baseline to Post-Operation

  Baseline assessment will be done pre-operatively. Four weeks after device programming, the patients will attend the DBS clinic with bilateral electrodes on to asses quality of life post surgery.

• Change of Overall Assessment of the Speaker's Experience of Stuttering (OASES) from Baseline to Post-Operation

  Baseline assessment will be done pre-operatively. Four weeks after device programming, the patients will attend the DBS clinic with bilateral electrodes on to asses subjective voice experience post surgery.

Study Arms (1)

Deep Brain Simulation (DBS) System

EXPERIMENTAL

The DBS device will be turned on to compare stutter to when the device was off (which would be the control).

Device: System On; Device: System off

Interventions

System On DEVICE

The DBS system will be turned on, and the individual's stutter will be assessed.

Deep Brain Simulation (DBS) System

System off DEVICE

The DBS system will be turned off, and the individual's stutter will be assessed.

Deep Brain Simulation (DBS) System

Eligibility Criteria

• Age: 19 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between the ages of 19 and 76 years old
• Individuals with persistent developmental stutter refractory to intensive speech therapy, as diagnosed by a speech and language therapist.

You may not qualify if:

• Children and adolescents will not be included, as there is a significant percentage of developmental stuttering that will spontaneously resolve in this age group.
• Patients who have not trialed standard therapy will not be included in this study.
• Patients with mild symptoms.
• Patients who have a neurodegenerative disease.
• Patients with a bleeding diathesis.
• Patients who are unable to communicate.
• Patients with a cardiac pacemaker or defibrillator.
• Patient with an insulin or infusion pump.
• Patients with a cochlear, otologic, or ear implant.
• Patients with an implant held in place by a magnet.
• Patients with tissue expanders.
• Patients with implanted clips, catheters, clamps, valves, or other metal.
• Patients with tattoos or permanent makeup above shoulders.
• Patients with shrapnel or other retained metal.
• Patients who are pregnant.

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Conditions

Childhood-Onset Fluency Disorder; Stuttering

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders; Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Danielle Pietramala

CONTACT

604-875-4111; danielle.pietram@ubc.ca

Christopher R Honey

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery

Model Details: Each participant will act as their own control. Each individual's stutter will be assessed with DBS system OFF (control) and DBS ON (treatment).

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 8, 2022
• Study Start: November 1, 2023
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-10