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

Sponsor
Luzerner Kantonsspital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04699149
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
20.6
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Transcranial magnetic stimulation
  • Other: Sham transcranial magnetic stimulation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
blinded randomised clinical trialblinded randomised clinical trial
Masking:
Single (Participant)
Masking Description:
rTMS protocol either sham or real
Primary Purpose:
Treatment
Official Title:
Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease: a Randomized Controlled Pilot-study
Actual Study Start Date :
Nov 11, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: real stimulation

The PD patients randomized in the experimental group will receive VBT each time preceded by a real rTMS stimulation.

Other: Transcranial magnetic stimulation
Non-invasive brain stimulation
Sham Comparator: sham stimulation

The PD patients randomized in the control group will receive VBT each time preceded by a sham TMS.

Other: Sham transcranial magnetic stimulation
Non-invasive brain stimulation

Outcome Measures

Primary Outcome Measures

  1. DextQ-24 [3 weeks]

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

Secondary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Luzerner Kantonsspital Lucerne Switzerland 6000

Sponsors and Collaborators

  • Luzerner Kantonsspital

Investigators

  • Principal Investigator: Tim Vanbellingen, Luzerner Kantonsspital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT04699149
Other Study ID Numbers:
  • EKNZ 2019-00433
First Posted:
Jan 7, 2021
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Luzerner Kantonsspital
transcranial magnetic stimulation
dexterity
video game-based training
Additional relevant MeSH terms:
Parkinson Disease

Study Results

No Results Posted as of Apr 7, 2022