tACS Modulates Speech and Cognitive Impairments in People With PD by Targeting the Medial Frontal Cortex

NCT ID: NCT07240272

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. Can tACS stimulation of the MFC improve executive functions in people with PD (such as reasoning, planning, inhibition, and complex problem-solving)?
2. 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:

1. Receive one extra 20-minute session of either real or sham tACS each day for two weeks
2. Attend clinic visits before stimulation, right after the 2-week period, and again at 1 month and 3 months for assessments and tests
3. Have their executive function scores, speech performance, and related brain activity recorded

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

6Hz-group

Group Type EXPERIMENTAL

6Hz-tACS

Intervention Type 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.

Sham-group

Group Type SHAM_COMPARATOR

Sham-tACS

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

6Hz-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.

Intervention Type OTHER

Sham-tACS

Except for turning down the current intensity to zero during the 20-minute period, all other parameters are identical to those in 6Hz-group.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Clinical diagnosis of Parkinson's disease.
2. Aged 35-80 years.
3. Absence of non-PD neurological disorders.
4. No hearing impairment, dementia, psychiatric abnormalities, or history of neurosurgical treatment.

Exclusion Criteria

1. Pregnancy.
2. Any contraindications to electrical stimulation.
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ke Dong, MD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ke Dong, MD

Research Associate

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Nos.82172528

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

tDCS on Parkinson's Disease Cognition
NCT03025334 RECRUITING NA
Mid-frontal Delta/Theta and Cognitive Control
NCT06984757 ENROLLING_BY_INVITATION NA