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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6Hz-group | Experimental |
| |
| Sham-group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6Hz-tACS | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
All IPD that underlie results in a publication.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D013064 | Speech Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Sham-tACS | Other | Except for turning down the current intensity to zero during the 20-minute period, all other parameters are identical to those in 6Hz-group. |
|
| Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups. |
| 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. | Assessments were completed at baseline, after two weeks of stimulation, and at 1- and 3-month follow-ups. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |