Parkinson DiseaseNESCIO-PDNCT06399731
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
A study testing High-frequency (10Hz) rTMS and Anodal tDCS in people with Parkinson Disease and Mild Cognitive Impairment, run by Amsterdam UMC at 1 site in Netherlands.
Trial summary
This cross-over pilot study aims to study the acceptability of two methods of non-invasive brain stimulation for the treatment of Parkinson's disease mild cognitive impairment (PD-MCI) - repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) targeted at the left… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Mild Cognitive Impairment
- What is being tested?
- High-frequency (10Hz) rTMS and Anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 May 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinical diagnosis of Parkinson's disease, diagnosed by a neurologist;
- Mild to moderate disease stage (Hoehn \& Yahr disease stage < 4);
- Movement Disorders Society level I criteria for PD-MCI (Litvan et al., 2012):
- Montreal Cognitive Assessment score range [21-25] (Dalrymple-Alford et al., 2010), or
- performance 1-2 SD below appropriate norms on at least 2 neuropsychological tests, or
- classification of PD-MCI based on recent (< 6 months previous to participation) neuropsychological assessment taken elsewhere (report will be requested);- In case of (dopaminergic) medication use, participants are on stable medication for at least one month before participation and expect to remain on stable medication during the study
Who cannot join
- Indication for dementia based on the SAGE (cut-off ≤ 14; Scharre et al., 2010);
- Severe depressive disorder (Beck Depression Inventory - Ib score > 18);
- Psychotic disorder (except for benign hallucinations with insight), screened with the Scale for Assessment of Positive Symptoms for Parkinson's disease;
- Indication of alcohol or drug abuse;
- Contra-indication for rTMS according to Magstim Rapid2 Manual; rTMS should not be:
- used on or in the vicinity of patients or users with cardiac demand pacemakers, implanted medication pumps, cochlear devices, implanted defibrillators and/or implanted neurostimulators
Show all 46Show fewer
- used on or in the vicinity of patients with implanted metal objects• used on patients where the skin in the area to be contacted is broken
- used on those with large ischaemic scars
- used on pregnant women
- used on infants under the age of 2 years
- used on epileptic individuals
- used on those with a family history of convulsions
- used on individuals with brain lesions that could affect seizure threshold
- used on individuals suffering from multiple sclerosis
- used on individuals taking tricyclic antidepressants, neuroleptic agents or any other drug that could lower seizure threshold,
- used on individuals suffering from sleep deprivation during rTMS procedures
- used on individuals with a heavy consumption of alcohol or those using epileptogenic drugs
- used on individuals with severe heart disease or with increased intracranial pressure be used on those who have uncontrolled migraines
- Contra-indication for tDCS according to Neuroelectrics Starstim Manual; tDCS should not be used in case of:
- Patients with a history of seizures;
- Patients with unexplained episodes of loss of consciousness, since such condition could be related with brain alterations or epilepsy;
- Patients with unstable or non-controlled neuropsychiatric illness;
- Patients having implanted brain medical devices;
- Patients with implanted pacemakers;
- Patients having any electrically, magnetically or mechanically activated implant;
- Patients having cardiac, neural or medication implants;
- Patients having vascular clips or any other electrically sensitive support system in the brain;
- Patients with serious brain injury;
- Patients showing damage of skin at sites of stimulation (the device can only be used in healthy skin without wounds, otherwise the resistance to current can be altered);
- Patients suffering from skin problems, such as dermatitis, psoriasis or eczema;
- Patients suffering from severe or frequent headaches;
- Patients with any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease or active neoplasia;
- Pregnant women (women of childbearing age should undertake a pregnancy test to confirm eligibility before treatment).
- Contra-indication for MR imaging:
- metal in the body (pacemaker, port-a-cath, prosthesis, (cochlear) implant)
- previous brain surgery
- head trauma that resulted in unconsciousness for at least 1 hour
- clips
- (old metal containing) tattoo
- irremovable piercings
- irremovable metal braces
- pregnancy
- claustrophobia other problems lying still for 45 minutes
- metal in the teeth
- neurostimulator (including deep brain stimulation)
- Space-occupying lesion on MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland
Tim D van Balkom, PhD, +31625694901, t.vanbalkom@amsterdamumc.nl
Chris Vriend, PhD
About this study
Official title: NEuroStimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease: an Acceptability Cross-over Study
This cross-over pilot study aims to study the acceptability of two methods of non-invasive brain stimulation for the treatment of Parkinson's disease mild cognitive impairment (PD-MCI) - repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) targeted at the left dorsolateral prefrontal cortex (DLPFC). Twenty participants will undergo both interventions in a cross-over design. They sequentially undergo four consecutive phases (4 weeks each), 1) no-intervention baseline, 2) rTMS ór tDCS, 3) no-intervention, 4) second intervention. The primary outcome measure will be acceptability of the interventions, and secondary outcomes include feasibility, cognitive function, neuropsychiatric symptoms, motor function. We will use MRI to explore personalized targeting.
Read the detailed description
RATIONALE: Mild cognitive impairment (MCI) is a highly prevalent non-motor characteristic affecting about 40% of individuals with Parkinson's disease (PD). PD-MCI negatively impacts daily life functioning and quality of life and is associated with presence of other neuropsychiatric symptoms. Importantly, it constitutes a risk factor for later development of PD-related dementia.
Despite many endeavours to pharmacologically improve PD-MCI, there is currently no effective treatment. Optimization of dopaminergic therapy in early PD can relieve cognitive deficits, improving cognitive inflexibility and bradyphrenia, but also exacerbating other cognitive domains. Additionally, other non-pharmacological treatment options such as cognitive training have shown moderate effect sizes, but with limited transfer to daily functioning.
Non-invasive brain stimulation (NIBS) through repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has promise in treating PD-MCI. NIBS, particularly institute-based rTMS, is, however, intensive and complex in use, specifically for individuals with motor and cognitive difficulties, which might limit its potential for clinical use.
OBJECTIVE: To study the acceptability and feasibility of rTMS and tDCS for the treatment of individuals with PD-MCI.
STUDY DESIGN: A cross-over design with three conditions: a baseline condition, rTMS, and tDCS. The study consists of 1) two four-week intervention periods, with rTMS treatment three times a week (total session duration ~40 mins, treatment duration = 20 mins) and tDCS treatment five times a week (total session duration ~30 mins, treatment duration = 20 mins. For the rTMS intervention, stimulation will be performed at the Amsterdam UMC, location VUmc (and thus includes travel time); 2) one 120-minute assessment (baseline) that includes neuropsychological and motor assessment, and MR imaging, and four 60-minute assessments that only includes neuropsychological assessment.
STUDY POPULATION: We will enroll twenty individuals with PD-MCI, according to level I criteria by the Movement Disorders Society: Montreal Cognitive Assessment score range [21-25], performance 1-2 SD below appropriate norms on at least 2 neuropsychological tests, or recent (< 6 months) classification of PD-MCI on neuropsychological assessment elsewhere.
INTERVENTION: Participants will undergo four consecutive phases in this intervention study: 1) a no-intervention baseline phase, 2) 12 sessions of 20-minute institute-based repetitive transcranial magnetic stimulation (rTMS) (10 Hz) or 20 sessions of 20-minute at-home anodal high-definition transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC), 3) a second no-intervention baseline phase, 4) the second alternative NIBS intervention. All phases have a duration of 4 weeks and the order of the NIBS interventions is counterbalanced.
MAIN STUDY PARAMETERS: The primary outcome measure will be acceptability of the interventions, and secondary outcomes include feasibility, cognitive function, neuropsychiatric symptoms, motor function. We will use MRI to explore personalized targeting.
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Being tested
- High-frequency (10Hz) rTMS, Anodal tDCS
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency (10Hz) rTMSDevice
High-frequency (10 Hz) rTMS targeting the left DLPFC, based on fMRI-peak activation during performance of the Tower of London task, at 110% resting motor threshold intensity, corrected for scalp-cortex distance at the target location, for a total of 3000 pulses per session, using 30 trains of 10 seconds with 30-second inter-train intervals (total duration: 20 minutes), using neuronavigation to record the pulse location.
Anodal tDCSDevice
Anodal high-definition tDCS. The anode will be placed at the F3 EEG location, coordinates registered using neuronavigation on the first intervention session on-site, and cathodes at Fp1, Fz, C3 and F7, in a ring surrounding the anode, using π cm2 circular stimulation electrodes, stimulating the left DLPFC at 2 mA intensity for a duration of 20 minutes, 15 s ramp up and 15 s ramp down. After an initial on-site instructional tDCS session, the tDCS intervention will be delivered at home, in part remotely-supervised via MS Teams.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm 1: rTMS followed by tDCS | Experimental | Participants in intervention arm 1 will undergo four phases in the following order: 1) a no-intervention baseline phase, 2) 12 sessions of 20-minute institute-based repetitive transcranial magnetic stimulation (rTMS) (10 Hz) targeting the left DLPFC, 3) a second no-intervention baseline phase, 4) 20 sessions of 20-minute at-home anodal high-definition transcranial direct current stimulation (tDCS) targeting the left DLPFC. All phases have a duration of 4 weeks. Receives: Device: High-frequency (10Hz) rTMS; Device: Anodal tDCS |
| Intervention arm 2: tDCS followed by rTMS | Experimental | Participants in intervention arm 2 will undergo four phases in the following order: 1) a no-intervention baseline phase, 2) 20 sessions of 20-minute at-home anodal high-definition transcranial direct current stimulation (tDCS) targeting the left DLPFC, 3) a second no-intervention baseline phase, 4) 12 sessions of 20-minute institute-based repetitive transcranial magnetic stimulation (rTMS) (10 Hz) targeting the left DLPFC. All phases have a duration of 4 weeks. Receives: Device: High-frequency (10Hz) rTMS; Device: Anodal tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantative acceptability of the interventions (measured seperately)
Measured with Theoretical Framework of Acceptability questionnaire ("TFA-PD questionnaire") score, measuring seven domains of acceptability
Measured: Eight weeks and sixteen weeks (after first and second intervention)
Secondary outcomes (21)
Qualitative acceptability assessment of both interventions
Qualitative assessment from focus groups after study termination
Measured: After study termination (i.e., all participants finished)
Intervention compliance (feasibility)
Percent of missed intervention sessions
Measured: Eight weeks and sixteen weeks (during first and second intervention)
Intervention attrition (feasibility)
Count of dropped out participants
Measured: After study termination (i.e., all participants finished)
Usability of the tDCS device (feasibility)
System Usability Scale score
Measured: Eight weeks or sixteen weeks (after tDCS intervention)
Subjective cognitive function
PD-Cognitive Functional Rating Scale score
Measured: Four, eight, twelve and sixteen weeks
Subjective cognitive function
Cognitive Failures Questionnaire score
Measured: Four, eight, twelve and sixteen weeks
Global cognitive function
Montreal Cognitive Assessment score
Measured: Four, eight, twelve and sixteen weeks
Attention/mental processing speed
Trail Making Test A time
Measured: Four, eight, twelve and sixteen weeks
Executive function
Trail Making Test B time
Measured: Four, eight, twelve and sixteen weeks
Executive function/language
Letter Fluency score
Measured: Four, eight, twelve and sixteen weeks
Executive function
Tower of London Accuracy
Measured: Four, eight, twelve and sixteen weeks
Executive function
Tower of London Reaction Time
Measured: Four, eight, twelve and sixteen weeks
Episodic Memory
Rey Auditory Verbal Learning Test ("15 Woordentest") Direct Recall score
Measured: Four, eight, twelve and sixteen weeks
Episodic Memory
Rey Auditory Verbal Learning Test ("15 Woordentest") Delayed Recall score
Measured: Four, eight, twelve and sixteen weeks
Episodic Memory
Rey Auditory Verbal Learning Test ("15 Woordentest") Recognition score
Measured: Four, eight, twelve and sixteen weeks
Mental processing speed
Symbol Digit Modalities Test score
Measured: Four, eight, twelve and sixteen weeks
Verbal attention
Wechsler Adult Intelligence Scale IV-NL-Digit Span Forward
Measured: Four, eight, twelve and sixteen weeks
Working memory
Wechsler Adult Intelligence Scale IV-NL-Digit Span Backwards/Sorting
Measured: Four, eight, twelve and sixteen weeks
Depressive symptoms
Beck Depression Inventory-lb score
Measured: Four, eight, twelve and sixteen weeks
Anxiety symptoms
Parkinson Anxiety Scale score
Measured: Four, eight, twelve and sixteen weeks
Functional mobility
Timed Get-up and Go test score
Measured: Four, eight, twelve and sixteen weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start31 May 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
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.
- 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
- Crossover
- Model description
- Four consecutive phases: 1) a no-intervention baseline phase, 2) rTMS or tDCS, 3) a second no-intervention baseline phase, 4) the second NIBS intervention. All phases have a duration of 4 weeks and the order of the NIBS interventions is counterbalanced.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Van Balkom, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399731
- Sponsor's protocol ID
- 2023.0804
- Other IDs
- 10390052210003, NL84843.018.23
- Acronym
- NESCIO-PD
- Status last verified
- Oct 2026
- First submitted
- 1 May 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will commit to adhere to the findability, accessibility, interoperability and re-usability (FAIR) of the data collected during this study by publishing and sharing coded data and analysis code on online repositories to the limits of Dutch GDP regulations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEuroStimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease: an Acceptability Cross-over Study
- ClinicalTrials.gov ID
- NCT06399731
- Acronym / sponsor ID
- NESCIO-PD / 2023.0804
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Amsterdam UMCUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 6 May 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.
This cross-over pilot study aims to study the acceptability of two methods of non-invasive brain stimulation for the treatment of Parkinson's disease mild cognitive impairment (PD-MCI) - repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) targeted at the left dorsolateral prefrontal cortex (DLPFC). Twenty participants will undergo both interventions in a cross-over design. They sequentially undergo four consecutive phases (4 weeks each), 1) no-intervention baseline, 2) rTMS ór tDCS, 3) no-intervention, 4) second intervention. The primary outcome measure will be acceptability of the interventions, and secondary outcomes include feasibility, cognitive function, neuropsychiatric symptoms, motor function. We will use MRI to explore personalized targeting.
Detailed description
RATIONALE: Mild cognitive impairment (MCI) is a highly prevalent non-motor characteristic affecting about 40% of individuals with Parkinson's disease (PD). PD-MCI negatively impacts daily life functioning and quality of life and is associated with presence of other neuropsychiatric symptoms. Importantly, it constitutes a risk factor for later development of PD-related dementia.
Despite many endeavours to pharmacologically improve PD-MCI, there is currently no effective treatment. Optimization of dopaminergic therapy in early PD can relieve cognitive deficits, improving cognitive inflexibility and bradyphrenia, but also exacerbating other cognitive domains. Additionally, other non-pharmacological treatment options such as cognitive training have shown moderate effect sizes, but with limited transfer to daily functioning.
Non-invasive brain stimulation (NIBS) through repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has promise in treating PD-MCI. NIBS, particularly institute-based rTMS, is, however, intensive and complex in use, specifically for individuals with motor and cognitive difficulties, which might limit its potential for clinical use.
OBJECTIVE: To study the acceptability and feasibility of rTMS and tDCS for the treatment of individuals with PD-MCI.
STUDY DESIGN: A cross-over design with three conditions: a baseline condition, rTMS, and tDCS. The study consists of 1) two four-week intervention periods, with rTMS treatment three times a week (total session duration ~40 mins, treatment duration = 20 mins) and tDCS treatment five times a week (total session duration ~30 mins, treatment duration = 20 mins. For the rTMS intervention, stimulation will be performed at the Amsterdam UMC, location VUmc (and thus includes travel time); 2) one 120-minute assessment (baseline) that includes neuropsychological and motor assessment, and MR imaging, and four 60-minute assessments that only includes neuropsychological assessment.
STUDY POPULATION: We will enroll twenty individuals with PD-MCI, according to level I criteria by the Movement Disorders Society: Montreal Cognitive Assessment score range [21-25], performance 1-2 SD below appropriate norms on at least 2 neuropsychological tests, or recent (< 6 months) classification of PD-MCI on neuropsychological assessment elsewhere.
INTERVENTION: Participants will undergo four consecutive phases in this intervention study: 1) a no-intervention baseline phase, 2) 12 sessions of 20-minute institute-based repetitive transcranial magnetic stimulation (rTMS) (10 Hz) or 20 sessions of 20-minute at-home anodal high-definition transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC), 3) a second no-intervention baseline phase, 4) the second alternative NIBS intervention. All phases have a duration of 4 weeks and the order of the NIBS interventions is counterbalanced.
MAIN STUDY PARAMETERS: The primary outcome measure will be acceptability of the interventions, and secondary outcomes include feasibility, cognitive function, neuropsychiatric symptoms, motor function. We will use MRI to explore personalized targeting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Four consecutive phases: 1) a no-intervention baseline phase, 2) rTMS or tDCS, 3) a second no-intervention baseline phase, 4) the second NIBS intervention. All phases have a duration of 4 weeks and the order of the NIBS interventions is counterbalanced.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm 1: rTMS followed by tDCS | Experimental | Device: High-frequency (10Hz) rTMS, Device: Anodal tDCSParticipants in intervention arm 1 will undergo four phases in the following order: 1) a no-intervention baseline phase, 2) 12 sessions of 20-minute institute-based repetitive transcranial magnetic stimulation (rTMS) (10 Hz) targeting the left DLPFC, 3) a second no-intervention baseline phase, 4) 20 sessions of 20-minute at-home anodal high-definition transcranial direct current stimulation (tDCS) targeting the left DLPFC. All phases have a duration of 4 weeks. |
| Intervention arm 2: tDCS followed by rTMS | Experimental | Device: High-frequency (10Hz) rTMS, Device: Anodal tDCSParticipants in intervention arm 2 will undergo four phases in the following order: 1) a no-intervention baseline phase, 2) 20 sessions of 20-minute at-home anodal high-definition transcranial direct current stimulation (tDCS) targeting the left DLPFC, 3) a second no-intervention baseline phase, 4) 12 sessions of 20-minute institute-based repetitive transcranial magnetic stimulation (rTMS) (10 Hz) targeting the left DLPFC. All phases have a duration of 4 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of Parkinson's disease, diagnosed by a neurologist;
- Mild to moderate disease stage (Hoehn \& Yahr disease stage < 4);
- Movement Disorders Society level I criteria for PD-MCI (Litvan et al., 2012):
Key exclusion criteria (46 listed)
- Indication for dementia based on the SAGE (cut-off ≤ 14; Scharre et al., 2010);
- Severe depressive disorder (Beck Depression Inventory - Ib score > 18);
- Psychotic disorder (except for benign hallucinations with insight), screened with the Scale for Assessment of Positive Symptoms for Parkinson's disease;
- Indication of alcohol or drug abuse;
- Contra-indication for rTMS according to Magstim Rapid2 Manual; rTMS should not be:
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 |
|---|---|---|
| High-frequency (10Hz) rTMSHigh-frequency (10 Hz) rTMS targeting the left DLPFC, based on fMRI-peak activation during performance of the Tower of London task, at 110% resting motor threshold intensity, corrected for scalp-cortex distance at the target location, for a total of 3000 pulses per session, using 30 trains of 10 seconds with 30-second inter-train intervals (total duration: 20 minutes), using neuronavigation to record the pulse location. | Device | Intervention arm 1: rTMS followed by tDCS, Intervention arm 2: tDCS followed by rTMS |
| Anodal tDCSAnodal high-definition tDCS. The anode will be placed at the F3 EEG location, coordinates registered using neuronavigation on the first intervention session on-site, and cathodes at Fp1, Fz, C3 and F7, in a ring surrounding the anode, using π cm2 circular stimulation electrodes, stimulating the left DLPFC at 2 mA intensity for a duration of 20 minutes, 15 s ramp up and 15 s ramp down. After an initial on-site instructional tDCS session, the tDCS intervention will be delivered at home, in part remotely-supervised via MS Teams. | Device | Intervention arm 1: rTMS followed by tDCS, Intervention arm 2: tDCS followed by rTMS |
Primary outcome
Quantative acceptability of the interventions (measured seperately)
Time frame: Eight weeks and sixteen weeks (after first and second intervention)
Measured with Theoretical Framework of Acceptability questionnaire ("TFA-PD questionnaire") score, measuring seven domains of acceptability
21 secondary outcomes
Qualitative acceptability assessment of both interventions
Time frame: After study termination (i.e., all participants finished)
Intervention compliance (feasibility)
Time frame: Eight weeks and sixteen weeks (during first and second intervention)
Intervention attrition (feasibility)
Time frame: After study termination (i.e., all participants finished)
Usability of the tDCS device (feasibility)
Time frame: Eight weeks or sixteen weeks (after tDCS intervention)
Subjective cognitive function
Time frame: Four, eight, twelve and sixteen weeks
Subjective cognitive function
Time frame: Four, eight, twelve and sixteen weeks
Global cognitive function
Time frame: Four, eight, twelve and sixteen weeks
Attention/mental processing speed
Time frame: Four, eight, twelve and sixteen weeks
Executive function
Time frame: Four, eight, twelve and sixteen weeks
Executive function/language
Time frame: Four, eight, twelve and sixteen weeks
Executive function
Time frame: Four, eight, twelve and sixteen weeks
Executive function
Time frame: Four, eight, twelve and sixteen weeks
Episodic Memory
Time frame: Four, eight, twelve and sixteen weeks
Episodic Memory
Time frame: Four, eight, twelve and sixteen weeks
Episodic Memory
Time frame: Four, eight, twelve and sixteen weeks
Mental processing speed
Time frame: Four, eight, twelve and sixteen weeks
Verbal attention
Time frame: Four, eight, twelve and sixteen weeks
Working memory
Time frame: Four, eight, twelve and sixteen weeks
Depressive symptoms
Time frame: Four, eight, twelve and sixteen weeks
Anxiety symptoms
Time frame: Four, eight, twelve and sixteen weeks
Functional mobility
Time frame: Four, eight, twelve and sixteen weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. We will commit to adhere to the findability, accessibility, interoperability and re-usability (FAIR) of the data collected during this study by publishing and sharing coded data and analysis code on online repositories to the limits of Dutch GDP regulations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency (10Hz) rTMS and Anodal tDCS in people with Parkinson Disease and Mild Cognitive Impairment, run by Amsterdam UMC at 1 site in Netherlands.
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 6 inclusion and 46 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim D van Balkom, PhD (+31204441162, t.vanbalkom@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantative acceptability of the interventions (measured seperately) (time frame: Eight weeks and sixteen weeks (after first and second intervention)). 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 29 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.