NCT04699149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

2.7 years

First QC Date

January 6, 2021

Last Update Submit

September 4, 2023

Conditions

Parkinson Disease

Keywords

transcranial magnetic stimulationdexterityvideo game-based training

Outcome Measures

Primary Outcomes (1)

  • DextQ-24

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

    3 weeks

Secondary Outcomes (2)

  • Nine Hole Peg test (9-HPT)

    3 weeks

  • Coin rotation task (CRT)

    3 weeks

Study Arms (2)

real stimulation

ACTIVE COMPARATOR

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

Other: Transcranial magnetic stimulation

sham stimulation

SHAM COMPARATOR

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

Other: Sham transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulationOTHER

Non-invasive brain stimulation

real stimulation
Sham transcranial magnetic stimulationOTHER

Non-invasive brain stimulation

sham stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed PD
  • Hoehn \& Yahr I to IV
  • Age 50-80 years old
  • written and signed informed consent
  • dexterous difficulties-

You may not qualify if:

  • 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)
  • Participation in another interventional trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Related Publications (2)

  • Pastore-Wapp M, Kaufmann BC, Nyffeler T, Wapp S, Bohlhalter S, Vanbellingen T. Feasibility of a combined intermittent theta-burst stimulation and video game-based dexterity training in Parkinson's disease. J Neuroeng Rehabil. 2023 Jan 12;20(1):2. doi: 10.1186/s12984-023-01123-w.

    PMID: 36635679DERIVED

  • 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.

    PMID: 36188867DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Tim Vanbellingen

    Luzerner Kantonsspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
rTMS protocol either sham or real
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: blinded randomised clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 7, 2021

Study Start

November 11, 2020

Primary Completion

July 20, 2023

Study Completion

July 20, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)