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OpenTrials
Completed

NCT Number: NCT04699149

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed PD
  • Hoehn & Yahr I to IV
  • Age 50-80 years old
  • written and signed informed consent
  • dexterous difficulties-

Exclusion criteria

  • 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.

Treatment and study plan

Transcranial magnetic stimulation

Other

Non-invasive brain stimulation

Sham transcranial magnetic stimulation

Other

Non-invasive brain stimulation

Primary outcomes

  1. DextQ-24

    Time frame: 3 weeks

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

Secondary outcomes

  1. Nine Hole Peg test (9-HPT)

    Time frame: 3 weeks

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

  2. Coin rotation task (CRT)

    Time frame: 3 weeks

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

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Official study title

Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease: a Randomized Controlled Pilot-study

Acronym: rTMSVR

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 7, 2021
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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