Speech and Voice Outcomes Following HD-tDCS Over the Left SMA
ConditionParkinson Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLouisiana State University and A&M College
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Neurological disorders besides Parkinson's disease
Previous brain surgery including deep brain stimulation
Clinical diagnosis of dementia
Trial design
Design model
Parallel
Treatments tested in this trial
Active transcranial direct current stimulation
DeviceHD electrodes (diameter of 1.2 cm) will be placed on the participants' skull using an HD-tDCS cap (Soterix Medical Inc. New York) and based on 5-10 international montage. Active stimulations will be delivered by a 9 MxN Soterix HD-tES device for 20 minutes( 2 mA) per day for 5 days.
Sham transcranial direct current stimulation
DeviceHD electrodes (diameter of 1.2 cm) will be placed on the participants' skull using an HD-tDCS cap (Soterix Medical Inc. New York) and based on 5-10 international montage. Sham stimulations will be delivered by a 9 MxN Soterix HD-tES device. In the sham tDCS condition, the current is only on for 30 seconds before it is ramped back down to 0 milliamps (mA), although the electrodes are still worn for 20 minutes.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Active high definition transcranial direct current stimulation (HD-tDCS)Experimental treatment 1 intervention
Group B: Sham high definition transcranial direct current stimulation (HD-tDCS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Voice loudness measures
Acoustics measures of voice loudness including voice intensity (dB), shimmer (Cycle-to-cycle voice intensity perturbation) and smoothed cepstral peak prominence will be calculated for each participant.
Time frame
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.2
Fundamental frequency measures
Changes in the accuracy rate (percentage of correct repetitions) of non-word repetition
Time frame
Fundamental frequency (F0), jitter (Cycle-to-cycle voice F0 perturbation) and harmonic to noise ration will be calculated for each participant.3
Accuracy of syllable repetition
The number of syllables that correctly produced during syllable repetition task will be calculated for each participant.
Time frame
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.4
Speech rate
The speech rate ( number of syllables per second) will be calculated during a syllable repetition task for each participant.
Time frame
Speech rate will be measured at baseline, immediately after the last session of stimulation, one week and one month after the las stimulation session.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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