Parkinson DiseaserTMSVRNCT04699149
Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease
A study testing Transcranial magnetic stimulation in people with Parkinson Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
We investigate the effectiveness of a combined repetitive transcranial magnetic stimulation (rTMS) - video game-based training (VBT) dexterity intervention in Parkinson's diseases. The short and long-term benefits of this training program will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial magnetic stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Nov 2020to 20 Jul 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed PD
- Hoehn \& Yahr I to IV
- Age 50-80 years old
- written and signed informed consent
- dexterous difficulties-
Who cannot join
- Significant medical, psychiatric co-morbidity including dementia as defined by Montreal Cognitive Assessment (MOCA < 21)
- Inability to understand the scope of the study and to follow study procedures according to the protocol e.g. complete questionnaires (i.e. due to cognitive problems)
- Exclusion criteria for TMS and Sham application, such as current pregnancy, personal history of epilepsy or epileptic fits, and any psychiatric, neurologic, or medical history.
- Participation in another interventional trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease: a Randomized Controlled Pilot-study
We investigate the effectiveness of a combined repetitive transcranial magnetic stimulation (rTMS) - video game-based training (VBT) dexterity intervention in Parkinson's diseases. The short and long-term benefits of this training program will be evaluated. For these purposes, a blinded sham controlled randomized controlled trial will be performed.
Read the detailed description
Patients with Parkinson's disease (PD) often exhibit dexterous difficulties during the performance of activities of daily living (ADL) such as tying shoe laces, hand-writing, using remote controls, smartphone or tablet. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation is exergaming. To enhance training effects a combination of repetitive transcranial magnetic stimulation (rTMS) with exergaming will be tested.
- Conditions
- Parkinson Disease
- Being tested
- Transcranial magnetic stimulation, Sham transcranial magnetic stimulation
- Keywords
- transcranial magnetic stimulation, dexterity, video game-based training
- 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 magnetic stimulationOther
Non-invasive brain stimulation
Sham transcranial magnetic stimulationOther
Non-invasive brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| real stimulation | Active comparator | The PD patients randomized in the experimental group will receive VBT each time preceded by a real rTMS stimulation. Receives: Other: Transcranial magnetic stimulation |
| sham stimulation | Sham comparator | The PD patients randomized in the control group will receive VBT each time preceded by a sham TMS. Receives: Other: Sham transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
DextQ-24
standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD
Measured: 3 weeks
Secondary outcomes (2)
Nine Hole Peg test (9-HPT)
The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD.
Measured: 3 weeks
Coin rotation task (CRT)
The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start11 Nov 2020
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Model description
- blinded randomised clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Vanbellingen, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699149
- Sponsor's protocol ID
- EKNZ 2019-00433
- Acronym
- rTMSVR
- Status last verified
- Sep 2023
- First submitted
- 6 Jan 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pastore-Wapp M, Kaufmann BC, Nyffeler T, Wapp S, Bohlhalter S, Vanbellingen T. Feasibility of a combined intermittent theta-burst stimulation and video game-based dexterity training in Parkinson's disease. J Neuroeng Rehabil. 2023 Jan 12;20(1):2. doi: 10.1186/s12984-023-01123-w.
PubMed 36635679Pastore-Wapp M, Lehnick D, Nef T, Bohlhalter S, Vanbellingen T. Combining Repetitive Transcranial Magnetic Stimulation and Video Game-Based Training to Improve Dexterity in Parkinson's Disease: Study Protocol of a Randomized Controlled Trial. Front Rehabil Sci. 2021 Nov 23;2:777981. doi: 10.3389/fresc.2021.777981. eCollection 2021.
PubMed 36188867
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease: a Randomized Controlled Pilot-study
- ClinicalTrials.gov ID
- NCT04699149
- Acronym / sponsor ID
- rTMSVR / EKNZ 2019-00433
- Conditions
- Parkinson Disease
- Keywords
- transcranial magnetic stimulation, dexterity, video game-based training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 7 Jan 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.
We investigate the effectiveness of a combined repetitive transcranial magnetic stimulation (rTMS) - video game-based training (VBT) dexterity intervention in Parkinson's diseases. The short and long-term benefits of this training program will be evaluated. For these purposes, a blinded sham controlled randomized controlled trial will be performed.
Detailed description
Patients with Parkinson's disease (PD) often exhibit dexterous difficulties during the performance of activities of daily living (ADL) such as tying shoe laces, hand-writing, using remote controls, smartphone or tablet. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation is exergaming. To enhance training effects a combination of repetitive transcranial magnetic stimulation (rTMS) with exergaming will be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- blinded randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| real stimulation | Active comparator | Other: Transcranial magnetic stimulationThe PD patients randomized in the experimental group will receive VBT each time preceded by a real rTMS stimulation. |
| sham stimulation | Sham comparator | Other: Sham transcranial magnetic stimulationThe PD patients randomized in the control group will receive VBT each time preceded by a sham TMS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed PD
- Hoehn \& Yahr I to IV
- Age 50-80 years old
- written and signed informed consent
- dexterous difficulties-
Key exclusion criteria (4 listed)
- Significant medical, psychiatric co-morbidity including dementia as defined by Montreal Cognitive Assessment (MOCA < 21)
- Inability to understand the scope of the study and to follow study procedures according to the protocol e.g. complete questionnaires (i.e. due to cognitive problems)
- Exclusion criteria for TMS and Sham application, such as current pregnancy, personal history of epilepsy or epileptic fits, and any psychiatric, neurologic, or medical history.
- Participation in another interventional trial.
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 magnetic stimulationNon-invasive brain stimulation | Other | real stimulation |
| Sham transcranial magnetic stimulationNon-invasive brain stimulation | Other | sham stimulation |
Primary outcome
DextQ-24
Time frame: 3 weeks
standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD
2 secondary outcomes
Nine Hole Peg test (9-HPT)
Time frame: 3 weeks
Coin rotation task (CRT)
Time frame: 3 weeks
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 6 Sep 2023.
- Derived from this study: PubMed 36635679Pastore-Wapp M, Kaufmann BC, Nyffeler T, Wapp S, Bohlhalter S, Vanbellingen T. Feasibility of a combined intermittent theta-burst stimulation and video game-based dexterity training in Parkinson's disease. J Neuroeng Rehabil. 2023 Jan 12;20(1):2. doi: 10.1186/s12984-023-01123-w.
- Derived from this study: PubMed 36188867Pastore-Wapp M, Lehnick D, Nef T, Bohlhalter S, Vanbellingen T. Combining Repetitive Transcranial Magnetic Stimulation and Video Game-Based Training to Improve Dexterity in Parkinson's Disease: Study Protocol of a Randomized Controlled Trial. Front Rehabil Sci. 2021 Nov 23;2:777981. doi: 10.3389/fresc.2021.777981. eCollection 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.
Tim Vanbellingen principal investigator
Luzerner Kantonsspital
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 magnetic stimulation in people with Parkinson Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 4 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 6 Sep 2023. 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 Switzerland. 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?
DextQ-24 (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699149, which also lists 2 linked publications.
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 6 Sep 2023.