Clinical trial NCT04699149: Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease
Official title: Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease: a Randomized Controlled Pilot-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: transcranial magnetic stimulation
dexterity
video game-based training
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: blinded randomised clinical trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: DextQ-24
timeFrame: 3 weeks
Secondary outcomes:
measure: Nine Hole Peg test (9-HPT)
timeFrame: 3 weeks
measure: Coin rotation task (CRT)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Luzerner Kantonsspital
name: Tim Vanbellingen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.