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

NCT ID: NCT06245070

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-02
• Study Completion Date: 2028-06-02

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active high definition transcranial direct current stimulation (HD-tDCS)

High-definition anodal transcranial direct current stimulation (2 milliamps \[mA\]) for 5 consecutive days (one session per day for 20 minutes each). The electrical current will be administered over the left Supplementary motor area. The stimulation will be delivered at an intensity of 2 milliamps (mA) for a maximum of 20 minutes.

Group Type: EXPERIMENTAL

Active transcranial direct current stimulation

Intervention Type: DEVICE

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.

Sham high definition transcranial direct current stimulation (HD-tDCS)

High-definition sham transcranial direct current stimulation (2 milliamps \[mA\]) for 5 consecutive days (one session per day for 20 minutes each). The electrical current will be administered over the left Supplementary motor area. The current will be ramped up for the first 30 seconds following which the intensity will drop to 0 milliamps (mA).

Group Type: EXPERIMENTAL

Sham transcranial direct current stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Louisiana State University and A&M College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Karim Johari

Role: CONTACT

karimjohari@lsu.edu

225-578-3934

Other Identifiers

IRBAM-21-1019

Identifier Type: -

Identifier Source: org_study_id