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

February 23, 2024 updated by: Louisiana State University and A&M College

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Experimental: 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voice loudness measures
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.
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.
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
Time Frame: Fundamental frequency (F0), jitter (Cycle-to-cycle voice F0 perturbation) and harmonic to noise ration will be calculated for each participant.
Changes in the accuracy rate (percentage of correct repetitions) of non-word repetition
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
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.
The number of syllables that correctly produced during syllable repetition task will be calculated for each participant.
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
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.
The speech rate ( number of syllables per second) will be calculated during a syllable repetition task for each participant.
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
Time Frame: 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.
Variability in speech rate across trials for each syllable length ( 1, 2, and 3 ) will be calculated for each participant.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University and A&M College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 2, 2025

Primary Completion (Estimated)

January 2, 2028

Study Completion (Estimated)

June 2, 2028

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBAM-21-1019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants' data are confidential. de-identified data will be publicly available after final analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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