Parkinson DiseaseNCT06245070
Speech and Voice Outcomes Following HD-tDCS Over the Left SMA
A study testing Active transcranial direct current stimulation in people with Parkinson Disease, run by Louisiana State University and A&M College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Active transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2025to 2 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neurological disorders besides Parkinson's disease
- Previous brain surgery including deep brain stimulation
- Clinical diagnosis of dementia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- Active transcranial direct current stimulation, Sham transcranial direct current stimulation
- Keywords
- Brain stimulation, Supplementary motor area, Speech, Voice
- Medical subject headings
- Parkinson Disease, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial direct current stimulationDevice
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 transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start2 Feb 2025 (estimated)
- Primary completion2 Jan 2028 (estimated)
- Study completion2 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University and A&M College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245070
- Sponsor's protocol ID
- IRBAM-21-1019
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' data are confidential. de-identified data will be publicly available after final analysis.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06245070
- Acronym / sponsor ID
- IRBAM-21-1019
- Conditions
- Parkinson Disease
- Keywords
- Brain stimulation, Supplementary motor area, Speech, Voice
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Louisiana State University and A&M CollegeUniversity, hospital or other
- Study start
- 2 Feb 2025 (estimated)
- Primary completion
- 2 Jan 2028 (estimated)
- Study completion
- 2 Jun 2028 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active high definition transcranial direct current stimulation (HD-tDCS) | Experimental | Device: Active transcranial direct current stimulationHigh-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. |
| Sham high definition transcranial direct current stimulation (HD-tDCS) | Experimental | Device: Sham transcranial direct current stimulationHigh-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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Neurological disorders besides Parkinson's disease
- Previous brain surgery including deep brain stimulation
- Clinical diagnosis of dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active transcranial direct current stimulationHD 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. | Device | Active high definition transcranial direct current stimulation (HD-tDCS) |
| Sham transcranial direct current stimulationHD 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. | Device | Sham high definition transcranial direct current stimulation (HD-tDCS) |
Primary outcome
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.
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
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.
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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No. Participants' data are confidential. de-identified data will be publicly available after final analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial direct current stimulation in people with Parkinson Disease, run by Louisiana State University and A&M College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim Johari (225-578-3934, karimjohari@lsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.