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

NCT ID: NCT04699149

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-11

Study Completion Date

2023-07-20

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

blinded randomised clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
rTMS protocol either sham or real

Study Groups

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real stimulation

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

Group Type ACTIVE_COMPARATOR

Transcranial magnetic stimulation

Intervention Type OTHER

Non-invasive brain stimulation

sham stimulation

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

Group Type SHAM_COMPARATOR

Sham transcranial magnetic stimulation

Intervention Type OTHER

Non-invasive brain stimulation

Interventions

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Transcranial magnetic stimulation

Non-invasive brain stimulation

Intervention Type OTHER

Sham transcranial magnetic stimulation

Non-invasive brain stimulation

Intervention Type OTHER

Eligibility Criteria

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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)
4. Participation in another interventional trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luzerner Kantonsspital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim Vanbellingen

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Locations

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Luzerner Kantonsspital

Lucerne, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 36635679 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36188867 (View on PubMed)

Other Identifiers

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EKNZ 2019-00433

Identifier Type: -

Identifier Source: org_study_id

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