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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Transcranial magnetic stimulation; Other: Sham transcranial magnetic stimulation

• Registration Number: NCT04699149
• Lead Sponsor: Luzerner Kantonsspital

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.

Study Timeline

• Study Start: 2020-11-11
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Primary Completion: 2023-07-20
• Study Completion: 2023-07-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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-

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
real stimulation	Transcranial magnetic stimulation	The PD patients randomized in the experimental group will receive VBT each time preceded by a real rTMS stimulation.
sham stimulation	Sham transcranial magnetic stimulation	The PD patients randomized in the control group will receive VBT each time preceded by a sham TMS.

Primary Outcome Measures

Name	Time	Method
DextQ-24	3 weeks	standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD

Secondary Outcome Measures

Name	Time	Method
Coin rotation task (CRT)	3 weeks	The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD.
Nine Hole Peg test (9-HPT)	3 weeks	The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD.

Trial Locations

Locations (1)

Luzerner Kantonsspital; 🇨🇭 Lucerne, Switzerland