Transcranial Direct Current StimulationNCT06566313
An Open-label Study on the Clinical Efficacy of tDCS Intervention in PD
A study testing transcranial Direct Current Stimulation in people with Transcranial Direct Current Stimulation and Parkinson Disease, run by Anhui Medical University at 1 site in China.
Trial summary
To demonstrate that intervention targeting the primary motor area (M1) using transcranial Direct Current Stimulation can improve sleep symptoms in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transcranial Direct Current Stimulation, Parkinson Disease, Primary Left Motor Cortex
- What is being tested?
- transcranial Direct Current Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Apr 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The diagnosis of PD was determined by neurologists with rich clinical work experience, and was in line with the diagnostic criteria for Parkinson's disease in China (2016 edition).
- The total score of RBD Screening Questionnaire (RBDSQ) is ≥6 points.
- All patients took the drug stably and had no history of drug adjustment within 2 months before treatment. The test was conducted 2 hours after taking the drug.
- Good compatibility, with a certain degree of compliance;
- Normal mental condition, able to cooperate with behavioral tests and transcranial electrical stimulation treatment;
Who cannot join
- The patient has a metal object or skull brace device or any similar metal object on the scalp;
- Head tremor or limb shaking is so severe that it is difficult to calmly receive treatment;
- The presence of other serious mental illness (such as major depression, psychosis or obsessive-compulsive disorder, physical illness or a history of substance abuse);
- Have a head injury, stroke or other neurological disorder;
- The diagnosis of PD dementia is difficult to complete the assessment.
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrate that intervention targeting the primary motor area (M1) using transcranial Direct Current Stimulation can improve sleep symptoms in patients with Parkinson's disease.
Read the detailed description
Rapid eye movement sleep behavior disorder (RBD) is one of the most common accompanying symptoms of Parkinson's disease (PD). PD-RBD patients have more severe clinical manifestations, require larger drug doses, and have more non-motor symptoms. Although several strategies using transcranial direct current stimulation (tDCS) have been investigated for the treatment of sleep disorders, the efficacy of high-definition tDCS (HD-tDCS) in PD-RBD patients remains unclear.
We conducted an open-label study using the RBD-SQ to identify individuals with possible RBD (pRBD), and recruiting the patients at the First Affiliated Hospital of Anhui Medical University to receive cathodal HD-tDCS intervention. On the basis of conventional anti-PD drugs, cathodal HD-tDCS treatment was performed on the left M1 area once a day for 20 minutes, and the treatment was continued for 10 days. The International Movement Disorders Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the Hoehn \& Yahr staging scale (H\&Y), REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), RBD Screening Questionnaire Hong Kong (RBDSQ- HK), Pittsburgh sleep quality index (PSQI), Epworth Sleepiness Scale (ESS), and Parkinson disease sleep scale (PDSS) were assessed on intervention Day 1 and Day 10, and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.
- Being tested
- transcranial Direct Current Stimulation
- Keywords
- Transcranial Direct Current Stimulation, Parkinson Disease, primary left motor cortex
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current StimulationBehavioural
On the basis of conventional anti-PD drugs, the left M1 region (based on the C3 coordinates of EEG 10-20 system and the surrounding FC1, FC5, CP1, CP5 coordinates) was treated with cathodic tDCS. The electrical stimulation intensity was 2.0mA, the treatment time was 20min, and the treatment lasted for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Experimental | a course of tDCS treatment is performed for 10 days Receives: Behavioral: transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBD Screening Questionnaire
The RBD Screening Questionnaire (RBDSQ) is the most widely used tool over the past decade and includes 13 yes-or-no questions regarding the presence of move- ments and dream-enacting behaviours during sleep(maximum total score 13 points) .
Measured: baseline; day 10
Secondary outcomes (5)
REM sleep behavior disorder questionnaire-Hong Kong
The RBDQ-HK questionnaire is a self-administered (by patient and/or bed partner) questionnaire comprising 13 questions per- taining to various clinical features of RBD as defined by the Inter- national Classification of Sleep Disorders (ICSD-II).The total RBD score was calcu- lated by the sum of the scores of all lifetime items and recent 1- year frequency items. The total RBD score has a range from 0 to 100.
Measured: baseline; day 10
Pittsburgh sleep quality index
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: baseline; day 10
EPworth Sleepiness Scale
The Epworth sleepiness scale (ESS) is asimple, self-administered questionnaire which is shown to provide a measurement of the subject's genera1level of daytime sleepiness.
Measured: baseline; day 10
Parkinson disease sleep scale
The PDSS is a visual analogue scale addressing 15 commonly reported symptoms associated with sleep disturbance.This is the description of a simple bedside screening instrument for evaluation of sleep disturbances in Parkinson's disease.
Measured: baseline; day 10
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale
The MDS-UPDRS is used to diagnose Parkinson's disease and assess the severity of symptoms, which is based on three major motor manifestations. Parkinson's disease is defined as bradykinesia with resting tremor, rigidity, or both.
Measured: baseline; day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
- Investigators
- Panpan Hu, MD, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566313
- Sponsor's protocol ID
- AHMU-tDCS-PD
- Status last verified
- Dec 2024
- First submitted
- 20 Aug 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study on the Clinical Efficacy of tDCS Intervention in PD
- ClinicalTrials.gov ID
- NCT06566313
- Acronym / sponsor ID
- AHMU-tDCS-PD
- Keywords
- Transcranial Direct Current Stimulation, Parkinson Disease, primary left motor cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 22 Aug 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.
To demonstrate that intervention targeting the primary motor area (M1) using transcranial Direct Current Stimulation can improve sleep symptoms in patients with Parkinson's disease.
Detailed description
Rapid eye movement sleep behavior disorder (RBD) is one of the most common accompanying symptoms of Parkinson's disease (PD). PD-RBD patients have more severe clinical manifestations, require larger drug doses, and have more non-motor symptoms. Although several strategies using transcranial direct current stimulation (tDCS) have been investigated for the treatment of sleep disorders, the efficacy of high-definition tDCS (HD-tDCS) in PD-RBD patients remains unclear.
We conducted an open-label study using the RBD-SQ to identify individuals with possible RBD (pRBD), and recruiting the patients at the First Affiliated Hospital of Anhui Medical University to receive cathodal HD-tDCS intervention. On the basis of conventional anti-PD drugs, cathodal HD-tDCS treatment was performed on the left M1 area once a day for 20 minutes, and the treatment was continued for 10 days. The International Movement Disorders Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the Hoehn \& Yahr staging scale (H\&Y), REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), RBD Screening Questionnaire Hong Kong (RBDSQ- HK), Pittsburgh sleep quality index (PSQI), Epworth Sleepiness Scale (ESS), and Parkinson disease sleep scale (PDSS) were assessed on intervention Day 1 and Day 10, and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Experimental | Behavioral: transcranial Direct Current Stimulationa course of tDCS treatment is performed for 10 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The diagnosis of PD was determined by neurologists with rich clinical work experience, and was in line with the diagnostic criteria for Parkinson's disease in China (2016 edition).
- The total score of RBD Screening Questionnaire (RBDSQ) is ≥6 points.
- All patients took the drug stably and had no history of drug adjustment within 2 months before treatment. The test was conducted 2 hours after taking the drug.
- Good compatibility, with a certain degree of compliance;
- Normal mental condition, able to cooperate with behavioral tests and transcranial electrical stimulation treatment;
Key exclusion criteria (5 listed)
- The patient has a metal object or skull brace device or any similar metal object on the scalp;
- Head tremor or limb shaking is so severe that it is difficult to calmly receive treatment;
- The presence of other serious mental illness (such as major depression, psychosis or obsessive-compulsive disorder, physical illness or a history of substance abuse);
- Have a head injury, stroke or other neurological disorder;
- The diagnosis of PD dementia is difficult to complete the assessment.
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 |
|---|---|---|
| transcranial Direct Current StimulationOn the basis of conventional anti-PD drugs, the left M1 region (based on the C3 coordinates of EEG 10-20 system and the surrounding FC1, FC5, CP1, CP5 coordinates) was treated with cathodic tDCS. The electrical stimulation intensity was 2.0mA, the treatment time was 20min, and the treatment lasted for 10 days. | Behavioural | tDCS group |
Primary outcome
RBD Screening Questionnaire
Time frame: baseline; day 10
The RBD Screening Questionnaire (RBDSQ) is the most widely used tool over the past decade and includes 13 yes-or-no questions regarding the presence of move- ments and dream-enacting behaviours during sleep(maximum total score 13 points) .
5 secondary outcomes
REM sleep behavior disorder questionnaire-Hong Kong
Time frame: baseline; day 10
Pittsburgh sleep quality index
Time frame: baseline; day 10
EPworth Sleepiness Scale
Time frame: baseline; day 10
Parkinson disease sleep scale
Time frame: baseline; day 10
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale
Time frame: baseline; day 10
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 18 Dec 2024.
- Individual participant dataSharing planned: No
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Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
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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.
Panpan Hu, MD principal investigator
The First Affiliated Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation in people with Transcranial Direct Current Stimulation and Parkinson Disease, run by Anhui Medical University 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 5 inclusion and 5 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 18 Dec 2024. 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. 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?
RBD Screening Questionnaire (time frame: baseline; day 10). 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 18 Dec 2024.