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CompletedNCT04699149rTMSVRUpdated Sep 6, 2023

Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease

An interventional study of Transcranial magnetic stimulation and Sham transcranial magnetic stimulation in Parkinson Disease, sponsored by Luzerner Kantonsspital. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by Luzerner Kantonsspital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Parkinson Disease

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Keywords

  • transcranial magnetic stimulation
  • dexterity
  • video game-based training
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Luzerner Kantonsspital is the lead sponsor of 60 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Confirmed PD
  2. Hoehn \& Yahr I to IV
  3. Age 50-80 years old
  4. written and signed informed consent
  5. dexterous difficulties-

Exclusion criteria

Exclusion Criteria:

  1. Significant medical, psychiatric co-morbidity including dementia as defined by Montreal Cognitive Assessment (MOCA \< 21)
  2. 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)
  3. 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.
  4. Participation in another interventional trial.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    real stimulation

    The PD patients randomized in the experimental group will receive VBT each time preceded by a real rTMS stimulation.

    Other: Transcranial magnetic stimulation

  • Sham comparator
    sham stimulation

    The PD patients randomized in the control group will receive VBT each time preceded by a sham TMS.

    Other: Sham transcranial magnetic stimulation

Interventions

  • OtherTranscranial magnetic stimulation

    Non-invasive brain stimulation

  • OtherSham transcranial magnetic stimulation

    Non-invasive brain stimulation

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What researchers measure

Primary outcomes

  1. DextQ-24

    standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD

    Time frame: 3 weeks

Secondary outcomes

  1. Nine Hole Peg test (9-HPT)

    The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD.

    Time frame: 3 weeks

  2. Coin rotation task (CRT)

    The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD.

    Time frame: 3 weeks

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Study locations

1 site
  • Luzerner Kantonsspital
    Lucerne, 6000, Switzerland
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References and documents

Publications

  • Pastore-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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04699149
Lead sponsor
Luzerner Kantonsspital
Responsible party
Sponsor
First posted
Jan 7, 2021
Start date
Nov 11, 2020
Primary completion
Jul 20, 2023
Completion
Jul 20, 2023
Last update
Sep 6, 2023

Study contacts

Tim Vanbellingen
principal investigator · Luzerner Kantonsspital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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