Speech and Voice Outcomes Following HD-tDCS Over the Left SMA

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Active transcranial direct current stimulation
  HD 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.
• Устройство Sham transcranial direct current stimulation
  HD 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.

Первичные конечные точки

• Voice loudness measures [Срок оценки: 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.]
• Fundamental frequency measures [Срок оценки: Fundamental frequency (F0), jitter (Cycle-to-cycle voice F0 perturbation) and harmonic to noise ration will be calculated for each participant.]
• Accuracy of syllable repetition [Срок оценки: 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.]
• Speech rate [Срок оценки: Speech rate will be measured at baseline, immediately after the last session of stimulation, one week and one month after the las stimulation session.]
• Speech rate stability [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06245070 · IRBAM-21-1019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗