Parkinson DiseaseNCT07240272
tACS Modulates Speech and Cognitive Impairments in People With PD by Targeting the Medial Frontal Cortex
A study testing 6Hz-tACS in people with Parkinson Disease, run by Ke Dong, MD at 1 site in China.
Trial summary
This clinical trial aims to study whether transcranial alternating current stimulation (tACS) applied to the medial frontal cortex (MFC) can improve speech and cognitive function in people with Parkinson's disease (PD), and to evaluate the safety of tACS. The main goals are to answer the following questions: 1. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 6Hz-tACS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson's disease.
- Aged 35-80 years.
- Absence of non-PD neurological disorders.
- No hearing impairment, dementia, psychiatric abnormalities, or history of neurosurgical treatment.
Who cannot join
- Pregnancy.
- Any contraindications to electrical stimulation.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Modulation of Executive Functions and Speech in Parkinson's Disease by Theta tACS Targeted at the Medial Frontal Cortex
This clinical trial aims to study whether transcranial alternating current stimulation (tACS) applied to the medial frontal cortex (MFC) can improve speech and cognitive function in people with Parkinson's disease (PD), and to evaluate the safety of tACS. The main goals are to answer the following questions:
- Can tACS stimulation of the MFC improve executive functions in people with PD (such as reasoning, planning, inhibition, and complex problem-solving)?
- Can it improve the integration of auditory information and speech motor control during communication?
Read more
Researchers will compare the effects of real tACS versus sham (placebo) stimulation to see if real stimulation leads to better speech and cognitive outcomes in PD patients.
Participants will:
- Receive one extra 20-minute session of either real or sham tACS each day for two weeks
- Attend clinic visits before stimulation, right after the 2-week period, and again at 1 month and 3 months for assessments and tests
- Have their executive function scores, speech performance, and related brain activity recorded
- Conditions
- Parkinson Disease
- Being tested
- 6Hz-tACS, Sham-tACS
- Keywords
- Parkinson's disease, transcranial alternating current stimulation, medial frontal cortex, executive functions, speech disorder
- Medical subject headings
- Parkinson Disease, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6Hz-tACSOther
tACS applied to the MFC at a frequency of 6 Hz, using a high-definition 1×4 electrode configuration with individualized current intensity, delivered for 20 minutes.
Sham-tACSOther
Except for turning down the current intensity to zero during the 20-minute period, all other parameters are identical to those in 6Hz-group.
| Study group | Role | What they receive |
|---|---|---|
| 6Hz-group | Experimental | Not described Receives: Other: 6Hz-tACS |
| Sham-group | Sham comparator | Not described Receives: Other: Sham-tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Fluency Test (VFT)
The VFT assesses abilities such as thought initiation, rapid word retrieval, and cognitive flexibility. It has two parts: 1.Phonemic Fluency Test (PFT), people needed to name as many Chinese words as possible beginning with "fa" or "xiao" within 60 seconds. 2.Semantic Fluency Test (SFT), people needed to name as many items as possible from categories such as "fruits," "vegetables," "animals," and "occupations" within 60 seconds. The number of correct and non-repeated words produced within the time limit were recorded.
Measured: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.
Digit Span Test (DST)
The DST assesses working memory and selective attention. People repeat a series of numbers in the same order (forward) or reverse order (backward) as spoken by the examiner. The maximum correctly repeated sequence length was recorded.
Measured: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.
Trail Making Test (TMT)
The TMT assesses complex visual scanning, conceptual tracking, cognitive flexibility and divided attention. It has two parts: TMT-A: People draw a trail by connecting 25 Arabic numbers in ascending order. TMT-B: the trail alternates between connecting 12 Arabic numbers and 12 Chinese characters. The time taken to complete each task is recorded.
Measured: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.
Speech motor integration ability as assessed by a well-established paradigm: frequency-altered feedback (FAF) task
In the FAF task, participants needed to sit in a sound-attenuated room and produce the vowel /u/ according to instructions. The acoustic signal is recorded and randomly shifted in pitch by an external device. The pitch-shifted voice is then fed back to the participant. This unexpected pitch perturbation elicits either an opposite or a following acoustic compensation response. The amplitude and timing of this response are recorded and used to assess the participant's speech-motor integration ability.
Measured: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Aug 2023
- Primary completion1 May 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ke Dong, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ke Dong, MD, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240272
- Sponsor's protocol ID
- Nos.82172528
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Dong K, Zhao Y, Zhu X, Li J, Peng B, Zhang Y, Li Y, Dai G, Liu D, Chang Y, Chen X, Liu H. Theta tACS Over the Medial Frontal Cortex Modulates Executive Function in Parkinson's Disease: A Randomized, Sham-Controlled Study. CNS Neurosci Ther. 2026 Jul;32(7):e71055. doi: 10.1002/cns.71055.
PubMed 42499269
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Executive Functions and Speech in Parkinson's Disease by Theta tACS Targeted at the Medial Frontal Cortex
- ClinicalTrials.gov ID
- NCT07240272
- Acronym / sponsor ID
- Nos.82172528
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, transcranial alternating current stimulation, medial frontal cortex, executive functions, speech disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ke Dong, MDUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 20 Nov 2025 (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.
This clinical trial aims to study whether transcranial alternating current stimulation (tACS) applied to the medial frontal cortex (MFC) can improve speech and cognitive function in people with Parkinson's disease (PD), and to evaluate the safety of tACS. The main goals are to answer the following questions:
- Can tACS stimulation of the MFC improve executive functions in people with PD (such as reasoning, planning, inhibition, and complex problem-solving)?
- Can it improve the integration of auditory information and speech motor control during communication?
Researchers will compare the effects of real tACS versus sham (placebo) stimulation to see if real stimulation leads to better speech and cognitive outcomes in PD patients.
Participants will:
- Receive one extra 20-minute session of either real or sham tACS each day for two weeks
- Attend clinic visits before stimulation, right after the 2-week period, and again at 1 month and 3 months for assessments and tests
- Have their executive function scores, speech performance, and related brain activity recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6Hz-group | Experimental | Other: 6Hz-tACS |
| Sham-group | Sham comparator | Other: Sham-tACS |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Parkinson's disease.
- Aged 35-80 years.
- Absence of non-PD neurological disorders.
- No hearing impairment, dementia, psychiatric abnormalities, or history of neurosurgical treatment.
Key exclusion criteria (2 listed)
- Pregnancy.
- Any contraindications to electrical stimulation.
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 |
|---|---|---|
| 6Hz-tACStACS applied to the MFC at a frequency of 6 Hz, using a high-definition 1×4 electrode configuration with individualized current intensity, delivered for 20 minutes. | Other | 6Hz-group |
| Sham-tACSExcept for turning down the current intensity to zero during the 20-minute period, all other parameters are identical to those in 6Hz-group. | Other | Sham-group |
Primary outcome
Verbal Fluency Test (VFT)
Time frame: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.
The VFT assesses abilities such as thought initiation, rapid word retrieval, and cognitive flexibility. It has two parts: 1.Phonemic Fluency Test (PFT), people needed to name as many Chinese words as possible beginning with "fa" or "xiao" within 60 seconds. 2.Semantic Fluency Test (SFT), people needed to name as many items as possible from categories such as "fruits," "vegetables," "animals," and "occupations" within 60 seconds. The number of correct and non-repeated words produced within the time limit were recorded.
Digit Span Test (DST)
Time frame: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.
The DST assesses working memory and selective attention. People repeat a series of numbers in the same order (forward) or reverse order (backward) as spoken by the examiner. The maximum correctly repeated sequence length was recorded.
Trail Making Test (TMT)
Time frame: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.
The TMT assesses complex visual scanning, conceptual tracking, cognitive flexibility and divided attention. It has two parts: TMT-A: People draw a trail by connecting 25 Arabic numbers in ascending order. TMT-B: the trail alternates between connecting 12 Arabic numbers and 12 Chinese characters. The time taken to complete each task is recorded.
Speech motor integration ability as assessed by a well-established paradigm: frequency-altered feedback (FAF) task
Time frame: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.
In the FAF task, participants needed to sit in a sound-attenuated room and produce the vowel /u/ according to instructions. The acoustic signal is recorded and randomly shifted in pitch by an external device. The pitch-shifted voice is then fed back to the participant. This unexpected pitch perturbation elicits either an opposite or a following acoustic compensation response. The amplitude and timing of this response are recorded and used to assess the participant's speech-motor integration ability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 42499269Dong K, Zhao Y, Zhu X, Li J, Peng B, Zhang Y, Li Y, Dai G, Liu D, Chang Y, Chen X, Liu H. Theta tACS Over the Medial Frontal Cortex Modulates Executive Function in Parkinson's Disease: A Randomized, Sham-Controlled Study. CNS Neurosci Ther. 2026 Jul;32(7):e71055. doi: 10.1002/cns.71055.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6Hz-tACS in people with Parkinson Disease, run by Ke Dong, MD at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Fluency Test (VFT) (time frame: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240272, which also lists 1 linked publication.
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 20 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.