Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Suitable participants are referred by speech pathology centers, after having failed an intensive speech therapy program. Referred participants are contacted by the Neurosurgery DBS Clinic, and assessed for suitability and willingness to participate.
These potential participants will be contacted by the DBS Clinic at Vancouver General Hospital to discuss the scope of the study, and educate them about deep brain stimulation. Those who wish to be included in the study will attend a face-to-face appointment at the DBS Clinic.
At the initial appointment, informed consent will take place. Baseline assessments will be undertaken, including the Overall Assessment of the Speaker's Experience of Stuttering (OASES), Voice-related Quality of Life (VRQoL), and "The One Page Stuttering Assessment". The participants will be referred for a functional MRI for mapping of speech and language laterality.
The participants will then undergo surgery for implantation of a bilateral thalamic DBS system. They will stay overnight in the hospital, and have a post-operative CT scan on the first post-operative day. This scan will be used to assess accuracy of electrode placement, as per usual technique.
4 weeks post-operatively, the participants will attend the DBS Clinic for programming of their devices.
4 weeks after device programming, the participants will attend the DBS clinic for 1-page stutter assessment with bilateral electrodes on, bilateral electrodes off, left electrode on, and right electrode on, as well as OASES and VRQoL.
The scores from the 1-page stutter assessment, as well as pre- and post-operative OASES and VRQoL, will be compared via the Wilcoxan rank sum test for nonparametric repeated measures.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| System On | Device | The DBS system will be turned on, and the individual's stutter will be assessed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Voice Related Quality of Life (VRQoL) from Baseline to Post-Operation | A 10-question, 5 point rating scale assessment, with higher scores reflecting a worse subjective voice-related quality of life. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
MRI Specific Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Pietramala | Contact | 604-875-4111 | 68396 | danielle.pietram@ubc.ca |
| Christopher R Honey | Contact |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000067454 | Childhood-Onset Fluency Disorder |
| D013342 | Stuttering |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D013064 | Speech Disorders |
Not provided
Not provided
Each participant will act as their own control. Each individual's stutter will be assessed with DBS system OFF (control) and DBS ON (treatment).
Not provided
Not provided
Not provided
Not provided
| System off | Device | The DBS system will be turned off, and the individual's stutter will be assessed. |
|
| Change of Overall Assessment of the Speaker's Experience of Stuttering (OASES) from Baseline to Post-Operation | 5-point scale that indicates the amount of adverse impact a person experiences due to stuttering, with higher scores indicating higher levels of negative impact. | 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. |
| D007806 |
| Language Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |