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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sham transcranial magnetic stimulation
Sponsored by
Luzerner Kantonsspital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring transcranial magnetic stimulation, dexterity, video game-based training

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Luzerner Kantonsspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

real stimulation

sham stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

DextQ-24
standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD

Secondary Outcome Measures

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

Full Information

First Posted
January 6, 2021
Last Updated
September 4, 2023
Sponsor
Luzerner Kantonsspital
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1. Study Identification

Unique Protocol Identification Number
NCT04699149
Brief Title
Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease
Acronym
rTMSVR
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
July 20, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luzerner Kantonsspital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
transcranial magnetic stimulation, dexterity, video game-based training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
blinded randomised clinical trial
Masking
Participant
Masking Description
rTMS protocol either sham or real
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
real stimulation
Arm Type
Active Comparator
Arm Description
The PD patients randomized in the experimental group will receive VBT each time preceded by a real rTMS stimulation.
Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm Description
The PD patients randomized in the control group will receive VBT each time preceded by a sham TMS.
Intervention Type
Other
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
Non-invasive brain stimulation
Intervention Type
Other
Intervention Name(s)
Sham transcranial magnetic stimulation
Intervention Description
Non-invasive brain stimulation
Primary Outcome Measure Information:
Title
DextQ-24
Description
standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Nine Hole Peg test (9-HPT)
Description
The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD.
Time Frame
3 weeks
Title
Coin rotation task (CRT)
Description
The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed PD Hoehn & Yahr I to IV Age 50-80 years old written and signed informed consent dexterous difficulties- Exclusion Criteria: Significant medical, psychiatric co-morbidity including dementia as defined by Montreal Cognitive Assessment (MOCA < 21) 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) 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. Participation in another interventional trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Vanbellingen
Organizational Affiliation
Luzerner Kantonsspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luzerner Kantonsspital
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36188867
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.
Results Reference
derived

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

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