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

NCT06245070 | Not Yet Recruiting

• 1 other identifier: IRBAM-21-1019
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

Brain stimulation; Supplementary motor area; Speech; Voice

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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

  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

  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

  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.

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

Active transcranial direct current stimulation 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.

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

Sham transcranial direct current stimulation 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.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Louisiana State University and A&M College: lead

MeSH Terms

Conditions

Parkinson Disease; Speech

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Verbal Behavior; Communication; Behavior

Central Study Contacts

Karim Johari

CONTACT

225-578-3934; karimjohari@lsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 7, 2024
• Study Start: February 2, 2025
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): June 2, 2028
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share