Combining Repetitive Transcranial Magnetic Stimulation and Video Game-Based Training to Improve Dexterity in Parkinson's Disease: Study Protocol of a Randomized Controlled Trial
Introduction: Patients with Parkinson's disease (PD) often exhibit difficulties with dexterity during the performance of activities of daily living (ADL) due to dysfunctional supplementary motor area (SMA). The aim of this clinical trial protocol work is to describe how the effectiveness of a c...
Guardado en:
| Autores principales: | , , , , |
|---|---|
| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
Frontiers Media S.A.
2021
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/c77b9216c1b24bd4bbcf64b362afa6ef |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:c77b9216c1b24bd4bbcf64b362afa6ef |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:c77b9216c1b24bd4bbcf64b362afa6ef2021-11-30T12:08:44ZCombining Repetitive Transcranial Magnetic Stimulation and Video Game-Based Training to Improve Dexterity in Parkinson's Disease: Study Protocol of a Randomized Controlled Trial2673-686110.3389/fresc.2021.777981https://doaj.org/article/c77b9216c1b24bd4bbcf64b362afa6ef2021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fresc.2021.777981/fullhttps://doaj.org/toc/2673-6861Introduction: Patients with Parkinson's disease (PD) often exhibit difficulties with dexterity during the performance of activities of daily living (ADL) due to dysfunctional supplementary motor area (SMA). The aim of this clinical trial protocol work is to describe how the effectiveness of a combined repetitive transcranial magnetic stimulation (rTMS) over SMA and video-game-based skill training (VBT) in PD will be evaluated. The short and long-term benefits are assessed.Methods and analysis: A single-blind (patients) stratified (based on Hoehn & Yahr) parallel randomized sham-controlled rTMS-VBT study with a baseline and two follow-up measurements (3 and 12 weeks) is being conducted. These measurements include the dexterity questionnaire 24 (DextQ-24) as a primary outcome, and nine hole peg test and coin rotation task as main secondary dexterity outcomes. Further secondary outcomes will be the subscale II of the movement disorders society unified PD rating scale (MDS-UPDRS) to assess improvements on overall ADL and the Parkinson's Disease Questionnaire-39 to assess quality of life. Thirty-six outpatients (from one neurorehabilitation center) with PD (diagnosis based on brain bank criteria) will be recruited who report difficulties with dexterity in performing ADL. All PD patients will receive a 45-min VBT three times a week for 3 weeks. The PD patients randomized in the experimental group will receive VBT preceded by real rTMS, being intermittent theta burst (iTBS) stimulation sessions. The PD patients randomized to the control group receive a VBT with sham rTMS.Discussion: The study will provide evidence to determine whether a combined iTBS and VBT skill intervention is more effective than a VBT intervention alone to improve dexterity in PD.Ethics and dissemination: The study was approved by the Ethics Committee for Northwest and Central Switzerland (EKNZ), Switzerland 2019–00433. The study will be conducted in accordance with the Helsinki Declaration and the Guidelines of Good Clinical Practice. Informed consent will be signed prior to subject enrolment. Dissemination will include submission to international peer-reviewed professional journals and presentation at international congresses.The study protocol has been registered in the clinicaltrials.gov registry with the identification code: NCT04699149.Manuela Pastore-WappManuela Pastore-WappDirk LehnickDirk LehnickTobias NefStephan BohlhalterStephan BohlhalterTim VanbellingenTim VanbellingenFrontiers Media S.A.articleParkinson's diseasetranscranial magnetic stimulationdexterityvideo game-based trainingRCT - randomized controlled trialOther systems of medicineRZ201-999Medical technologyR855-855.5ENFrontiers in Rehabilitation Sciences, Vol 2 (2021) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
Parkinson's disease transcranial magnetic stimulation dexterity video game-based training RCT - randomized controlled trial Other systems of medicine RZ201-999 Medical technology R855-855.5 |
| spellingShingle |
Parkinson's disease transcranial magnetic stimulation dexterity video game-based training RCT - randomized controlled trial Other systems of medicine RZ201-999 Medical technology R855-855.5 Manuela Pastore-Wapp Manuela Pastore-Wapp Dirk Lehnick Dirk Lehnick Tobias Nef Stephan Bohlhalter Stephan Bohlhalter Tim Vanbellingen Tim Vanbellingen Combining Repetitive Transcranial Magnetic Stimulation and Video Game-Based Training to Improve Dexterity in Parkinson's Disease: Study Protocol of a Randomized Controlled Trial |
| description |
Introduction: Patients with Parkinson's disease (PD) often exhibit difficulties with dexterity during the performance of activities of daily living (ADL) due to dysfunctional supplementary motor area (SMA). The aim of this clinical trial protocol work is to describe how the effectiveness of a combined repetitive transcranial magnetic stimulation (rTMS) over SMA and video-game-based skill training (VBT) in PD will be evaluated. The short and long-term benefits are assessed.Methods and analysis: A single-blind (patients) stratified (based on Hoehn & Yahr) parallel randomized sham-controlled rTMS-VBT study with a baseline and two follow-up measurements (3 and 12 weeks) is being conducted. These measurements include the dexterity questionnaire 24 (DextQ-24) as a primary outcome, and nine hole peg test and coin rotation task as main secondary dexterity outcomes. Further secondary outcomes will be the subscale II of the movement disorders society unified PD rating scale (MDS-UPDRS) to assess improvements on overall ADL and the Parkinson's Disease Questionnaire-39 to assess quality of life. Thirty-six outpatients (from one neurorehabilitation center) with PD (diagnosis based on brain bank criteria) will be recruited who report difficulties with dexterity in performing ADL. All PD patients will receive a 45-min VBT three times a week for 3 weeks. The PD patients randomized in the experimental group will receive VBT preceded by real rTMS, being intermittent theta burst (iTBS) stimulation sessions. The PD patients randomized to the control group receive a VBT with sham rTMS.Discussion: The study will provide evidence to determine whether a combined iTBS and VBT skill intervention is more effective than a VBT intervention alone to improve dexterity in PD.Ethics and dissemination: The study was approved by the Ethics Committee for Northwest and Central Switzerland (EKNZ), Switzerland 2019–00433. The study will be conducted in accordance with the Helsinki Declaration and the Guidelines of Good Clinical Practice. Informed consent will be signed prior to subject enrolment. Dissemination will include submission to international peer-reviewed professional journals and presentation at international congresses.The study protocol has been registered in the clinicaltrials.gov registry with the identification code: NCT04699149. |
| format |
article |
| author |
Manuela Pastore-Wapp Manuela Pastore-Wapp Dirk Lehnick Dirk Lehnick Tobias Nef Stephan Bohlhalter Stephan Bohlhalter Tim Vanbellingen Tim Vanbellingen |
| author_facet |
Manuela Pastore-Wapp Manuela Pastore-Wapp Dirk Lehnick Dirk Lehnick Tobias Nef Stephan Bohlhalter Stephan Bohlhalter Tim Vanbellingen Tim Vanbellingen |
| author_sort |
Manuela Pastore-Wapp |
| title |
Combining Repetitive Transcranial Magnetic Stimulation and Video Game-Based Training to Improve Dexterity in Parkinson's Disease: Study Protocol of a Randomized Controlled Trial |
| title_short |
Combining Repetitive Transcranial Magnetic Stimulation and Video Game-Based Training to Improve Dexterity in Parkinson's Disease: Study Protocol of a Randomized Controlled Trial |
| title_full |
Combining Repetitive Transcranial Magnetic Stimulation and Video Game-Based Training to Improve Dexterity in Parkinson's Disease: Study Protocol of a Randomized Controlled Trial |
| title_fullStr |
Combining Repetitive Transcranial Magnetic Stimulation and Video Game-Based Training to Improve Dexterity in Parkinson's Disease: Study Protocol of a Randomized Controlled Trial |
| title_full_unstemmed |
Combining Repetitive Transcranial Magnetic Stimulation and Video Game-Based Training to Improve Dexterity in Parkinson's Disease: Study Protocol of a Randomized Controlled Trial |
| title_sort |
combining repetitive transcranial magnetic stimulation and video game-based training to improve dexterity in parkinson's disease: study protocol of a randomized controlled trial |
| publisher |
Frontiers Media S.A. |
| publishDate |
2021 |
| url |
https://doaj.org/article/c77b9216c1b24bd4bbcf64b362afa6ef |
| work_keys_str_mv |
AT manuelapastorewapp combiningrepetitivetranscranialmagneticstimulationandvideogamebasedtrainingtoimprovedexterityinparkinsonsdiseasestudyprotocolofarandomizedcontrolledtrial AT manuelapastorewapp combiningrepetitivetranscranialmagneticstimulationandvideogamebasedtrainingtoimprovedexterityinparkinsonsdiseasestudyprotocolofarandomizedcontrolledtrial AT dirklehnick combiningrepetitivetranscranialmagneticstimulationandvideogamebasedtrainingtoimprovedexterityinparkinsonsdiseasestudyprotocolofarandomizedcontrolledtrial AT dirklehnick combiningrepetitivetranscranialmagneticstimulationandvideogamebasedtrainingtoimprovedexterityinparkinsonsdiseasestudyprotocolofarandomizedcontrolledtrial AT tobiasnef combiningrepetitivetranscranialmagneticstimulationandvideogamebasedtrainingtoimprovedexterityinparkinsonsdiseasestudyprotocolofarandomizedcontrolledtrial AT stephanbohlhalter combiningrepetitivetranscranialmagneticstimulationandvideogamebasedtrainingtoimprovedexterityinparkinsonsdiseasestudyprotocolofarandomizedcontrolledtrial AT stephanbohlhalter combiningrepetitivetranscranialmagneticstimulationandvideogamebasedtrainingtoimprovedexterityinparkinsonsdiseasestudyprotocolofarandomizedcontrolledtrial AT timvanbellingen combiningrepetitivetranscranialmagneticstimulationandvideogamebasedtrainingtoimprovedexterityinparkinsonsdiseasestudyprotocolofarandomizedcontrolledtrial AT timvanbellingen combiningrepetitivetranscranialmagneticstimulationandvideogamebasedtrainingtoimprovedexterityinparkinsonsdiseasestudyprotocolofarandomizedcontrolledtrial |
| _version_ |
1718406651374993408 |