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

Parkinson Disease Clinical Trial

— rTMSVR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699149
• Other study ID #: EKNZ 2019-00433
• Status: Completed
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: July 20, 2023

Study information

• Verified date: September 2023
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. For these purposes, a blinded sham controlled randomized controlled trial will be performed.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Transcranial magnetic stimulation
Non-invasive brain stimulation
• Sham transcranial magnetic stimulation
Non-invasive brain stimulation

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DextQ-24	standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD	3 weeks
Secondary	Nine Hole Peg test (9-HPT)	The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD.	3 weeks
Secondary	Coin rotation task (CRT)	The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD.	3 weeks