Clinical trial NCT06245070: Speech and Voice Outcomes Following HD-tDCS Over the Left SMA
Official title: Immediate and Short-term Effects of High-definition Transcranial Direct Current Stimulation Over the Left Supplementary Motor Area on Voice and Speech Functions in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Brain stimulation
Supplementary motor area
Speech
Voice
Lead sponsor: Louisiana State University and A&M College
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pharmaceutical and neurosurgical treatments reliably ameliorate the cardinal motor symptoms in PD but, they often yield inconsistent outcomes for speech and voice disorders, with some studies showing exacerbation of pre-treatment deficits. Therefore, it is crucial to develop and optimize novel approaches that could simultaneously improve speech and voice deficits in PD and facilitate existing behavioral interventions. This project will investigate the immediate and short-term effects of multiple sessions of HD-tDCS over the left SMA on speech and voice deficits in PD.

Detailed description: Parkinson's disease (PD) is a movement disorder that affects more than one million individuals in the United States. Over 90 percent of individuals with PD manifest speech and voice impairments in the course of their disease, which can significantly compromise patients' quality of life. While pharmaceutical intervention and deep brain stimulation reliably improve the cardinal motor symptoms of PD, such as tremor, rigidity, and bradykinesia, the effects of these treatments on speech and voice are inconsistent, with some studies showing the exacerbation of pre-treatment deficits. This inconsistency often occurs because treatments are calibrated to ameliorate limb motor symptoms, with no direct optimization to improve speech and voice functions. However, there is no established non-invasive neurostimulation protocol for communication disorders in PD. Increasing evidence supports the application of non-invasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) to improve both motor and non-motor symptoms in PD. However, limited evidence exists regarding the application of tDCS to improve speech and voice disorders in PD. Moreover, there is no established long-term effect of tDCS on speech and voice deficits in PD. In this proposed study, we will address these gaps by investigating the immediate and short-term effects of high definition-transcranial direct current stimulation (HD-tDCS) over the left supplementary motor area (SMA) on speech and voice deficits in 24 PD and 24 matched control participants.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease
* Native English speakers
* Adequate age-relative hearing and vision to perform the outlined tasks
* Able to provide their own written consent

Exclusion Criteria :

* Neurological disorders besides Parkinson's disease
* Previous brain surgery including deep brain stimulation
* Clinical diagnosis of dementia

Primary outcomes:
measure: Voice loudness measures
timeFrame: Acoustic measures related to voice loudness will be measured at baseline, immediately after the last session of stimulation, one week and one month after the las stimulation session.
measure: Fundamental frequency measures
timeFrame: Fundamental frequency (F0), jitter (Cycle-to-cycle voice F0 perturbation) and harmonic to noise ration will be calculated for each participant.
measure: Accuracy of syllable repetition
timeFrame: Accuracy rate for syllable repetition will be measured at baseline, immediately after the last session of stimulation, one week and one month after the las stimulation session.
measure: Speech rate
timeFrame: Speech rate will be measured at baseline, immediately after the last session of stimulation, one week and one month after the las stimulation session.
measure: Speech rate stability
timeFrame: Speech rate stability will be measured at baseline, immediately after the last session of stimulation, one week and one month after the las stimulation session.
Secondary outcomes:
Other outcomes:
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