An interventional study of 6Hz-tACS and Sham-tACS in Parkinson Disease, sponsored by Ke Dong, MD. Completed at 1 site in China. Open to participants aged 35 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Ke Dong, MD · Not applicable, Interventional, and Treatment
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:
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:
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 28 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Ke Dong, MD is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: 6Hz-tACS
Other: Sham-tACS
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.
Except for turning down the current intensity to zero during the 20-minute period, all other parameters are identical to those in 6Hz-group.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.
The event-related potentials (ERPs) components recorded by Electroencephalography (EEG)
During the FAF task, cortical electrical activity associated with the pitch perturbation event was simultaneously recorded. Using the perturbation onset as the zero point, a time window ranging from -500ms to 700ms was defined. The peak amplitude and latency of N1 and P2 components were extracted within 80-180 ms and 160-280 ms time windows after the perturbation onset, respectively.
Time frame: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.
The hemodynamic responses in the executive process as assessed by Functional Near-Infrared Spectroscopy (fNIRS)
The fNIRS monitoring was conducted during a VFT task consisting of multiple 30-second blocks. The average change in oxygenated hemoglobin concentration during the task was recorded.
Time frame: Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups.
Plan to share: Yes — All IPD that underlie results in a publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Ran from Aug 2023 to primary completion in May 2025, 21 months.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 21 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Ke Dong, MD