Parkinson DiseaseNCT04787406
Motor Learning and tDCS in Parkinson's Disease
A study testing Transcranial direct current stimulation in people with Parkinson Disease, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The present study sought to examine the efficacy of single session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Jan 2019to 27 Sep 2019
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right-handed (Edinburgh Handedness Inventory; ≥50)
- Cognitively capable (Montreal Cognitive Assessment (MoCA); ≥23)
- Mild to moderate Parkinson's disease severity (Hoehn and Yar disease stage 2-3)
Who cannot join
- History of stroke
- Comorbidity
- Cephalic implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Single Session Transcranial Direct Current Stimulation on Sequential Motor Learning in Parkinson's Disease
The present study sought to examine the efficacy of single session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance.
Read the detailed description
Parkinson's disease is characterised by deficits of motor control triggered by impaired basal ganglia function, such as bradykinesia and tremor. Beyond the visibly recognisable motor symptoms of Parkinson's disease, the ability to learn a sequence of movements is also compromised and poses a significant barrier to effective rehabilitation. In healthy individuals, transcranial direct current stimulation applied over the primary motor cortex during motor task practice has been shown to significantly improve motor learning compared to placebo conditions. The present study sought to examine the effect of a single session of transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance. Participants learnt two finger tapping sequences, with task difficulty indexed by sequence length, and task consolidation further examined using a dual-task paradigm. Task related cortical haemodynamic activity was recorded using functional near-infrared spectroscopy.
- Conditions
- Parkinson Disease
- Being tested
- Transcranial direct current stimulation
- Keywords
- Parkinson's disease, Transcranial direct current stimulation, Motor sequence learning
- 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 stimulationDevice
Also called tDCS
Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad.
Stimulation is phased in with a 30 second ramp up period prior to the specified stimulation period and phased-out with a ramp down of the current following the specified stimulation period. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off for during the specified stimulation period.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Active comparator | Anodal electrode (35 cm2 sponge electrode) placed over C3. Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. 20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period. Receives: Device: Transcranial direct current stimulation |
| Cathodal tDCS | Active comparator | Cathodal electrode (35 cm2 sponge electrode) placed over C3. Anodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. 20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period. Receives: Device: Transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Anodal electrode (35 cm2 sponge electrode) placed over C3. Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. Stimulation was phased in for 30 seconds up to 2 mA and then switched off. Stimulation was again phased in for 30 seconds following 20 minutes of no stimulation. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline sequential finger tapping performance
A skill index reflecting the accuracy and speed of which participants perform a specified finger tapping sequence.
Measured: Two assessments: Baseline / pre-intervention, and immediately post-intervention
Change from baseline oxygenated haemoglobin response
Task related changes of oxygenated haemoglobin as measured using functional near-infrared spectroscopy.
Measured: Two assessments: Baseline / pre-intervention, and immediately post-intervention
Change from baseline shape-counting error
The percentage of shape counting error during dual task assessments. Sequential finger tapping + visual shape counting task.
Measured: Two assessments: Baseline / pre-intervention, and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start7 Jan 2019
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magaret Mak, Dr, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787406
- Sponsor's protocol ID
- HSEARS20181226002
- Status last verified
- Feb 2021
- First submitted
- 1 Mar 2021
- Last updated
- 26 Aug 2021
- 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 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single Session Transcranial Direct Current Stimulation on Sequential Motor Learning in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04787406
- Acronym / sponsor ID
- HSEARS20181226002
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Transcranial direct current stimulation, Motor sequence learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 8 Mar 2021 (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.
The present study sought to examine the efficacy of single session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance.
Detailed description
Parkinson's disease is characterised by deficits of motor control triggered by impaired basal ganglia function, such as bradykinesia and tremor. Beyond the visibly recognisable motor symptoms of Parkinson's disease, the ability to learn a sequence of movements is also compromised and poses a significant barrier to effective rehabilitation. In healthy individuals, transcranial direct current stimulation applied over the primary motor cortex during motor task practice has been shown to significantly improve motor learning compared to placebo conditions. The present study sought to examine the effect of a single session of transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance. Participants learnt two finger tapping sequences, with task difficulty indexed by sequence length, and task consolidation further examined using a dual-task paradigm. Task related cortical haemodynamic activity was recorded using functional near-infrared spectroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Active comparator | Device: Transcranial direct current stimulationAnodal electrode (35 cm2 sponge electrode) placed over C3. Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. 20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period. |
| Cathodal tDCS | Active comparator | Device: Transcranial direct current stimulationCathodal electrode (35 cm2 sponge electrode) placed over C3. Anodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. 20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period. |
| Sham tDCS | Sham comparator | Device: Transcranial direct current stimulationAnodal electrode (35 cm2 sponge electrode) placed over C3. Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. Stimulation was phased in for 30 seconds up to 2 mA and then switched off. Stimulation was again phased in for 30 seconds following 20 minutes of no stimulation. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Right-handed (Edinburgh Handedness Inventory; ≥50)
- Cognitively capable (Montreal Cognitive Assessment (MoCA); ≥23)
- Mild to moderate Parkinson's disease severity (Hoehn and Yar disease stage 2-3)
Key exclusion criteria (3 listed)
- History of stroke
- Comorbidity
- Cephalic implants
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 stimulationAlso: tDCSTranscranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30 second ramp up period prior to the specified stimulation period and phased-out with a ramp down of the current following the specified stimulation period. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off for during the specified stimulation period. | Device | Anodal tDCS, Cathodal tDCS, Sham tDCS |
Primary outcome
Change from baseline sequential finger tapping performance
Time frame: Two assessments: Baseline / pre-intervention, and immediately post-intervention
A skill index reflecting the accuracy and speed of which participants perform a specified finger tapping sequence.
Change from baseline oxygenated haemoglobin response
Time frame: Two assessments: Baseline / pre-intervention, and immediately post-intervention
Task related changes of oxygenated haemoglobin as measured using functional near-infrared spectroscopy.
Change from baseline shape-counting error
Time frame: Two assessments: Baseline / pre-intervention, and immediately post-intervention
The percentage of shape counting error during dual task assessments. Sequential finger tapping + visual shape counting task.
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 26 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Magaret Mak, Dr principal investigator
The Hong Kong Polytechnic 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 Parkinson Disease, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 3 inclusion and 3 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 26 Aug 2021. 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 Hong Kong. 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?
Change from baseline sequential finger tapping performance (time frame: Two assessments: Baseline / pre-intervention, and immediately post-intervention). The study lists 3 primary outcomes in all. 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 26 Aug 2021.