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

L

Luzerner Kantonsspital

Status

Completed

Conditions

Parkinson Disease

Treatments

Other: Transcranial magnetic stimulation
Other: Sham transcranial magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04699149
EKNZ 2019-00433

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Manuela Pastore-Wapp

Data sourced from clinicaltrials.gov

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