Mental Imagery Neurofeedback in Strokerehabilitation

NCT03994042 | Completed

• 1 other identifier: 2019-01577
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief Summary

This research project will investigate neurofeedback training in stroke rehabilitation during which patients receive feedback in real time from their brain activity measured with ElectroEncephaloGraphy (EEG). The investigators hypothesize that the feedback training allows to internally stimulate brain motor networks in order to promote functional recovery of the hand.

Conditions

Stroke; Hemiparesis

Outcome Measures

Primary Outcomes (3)

• Change of Fugl-Meyer Upper Extremity scale score (0-66 points)

  Arm and hand function

  Up to 10 weeks

• Change of EEG alpha and beta activity

  Brain motor network activity reflected in neurofeedback signal

  Up to 7 weeks

• Change of fMRI BOLD activity

  Brain motor network activity

  Up to 7 weeks

Secondary Outcomes (5)

• Change of monofilament test score

  Up to 10 weeks

• Change of box and block test score (0-150)

  Up to 10 weeks

• Change of JAMAR® digital Hand Dynamometer scores (0-90)

  Up to 10 weeks

• Change of visuomotor force-tracking task scores

  Up to 10 weeks

• Change of stroke Impact Scale 16 scores (15-80 points)

  Up to 10 weeks

Study Arms (1)

Mental imagery neurofeedback training

EXPERIMENTAL

Complete intervention with mental imagery neurofeedback training. Patients recruited by physioterapists who underwent baseline evaluations with clinical tests, fMRI and EEG measurements. Patients will after intervention perform clinical tests, fMRI, and EEG measurements to evaluate outcomes of intervention.

Device: Mental imagery neurofeedback training

Interventions

Mental imagery neurofeedback training DEVICE

Mental Imagery (MI)-neurofeedback training, 2-3 hours, 3 times/week for 4 weeks.

Mental imagery neurofeedback training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 6 months since first time stroke onset and with remaining hemiparesis in upper extremity;
• able to participate fully in the intervention including screening of cognitive function with the Cambridge Neuropsychological Test Automated Battery;
• able to perform Functional Magnetic Resonance Imaging (fMRI);
• able to passively extend the wrist 15 degrees and extend fingers fully with a neutral position of the wrist.
• Subgroup 1 (n=2):
• be able to voluntarily control the power of their grip when requested according to the Visuomotor force tracking method and/or according to the clinical assessment of a therapist (while holding the patient´s hand).
• Fugl-Meyer Upper Extremity (UE) scale (Fugl-Meyer 1975): \<14 points on the hand subscale (C) in addition to \< 48 points on the total score (equivalent to moderate disability in the upper extremity
• Subgroup 2 (n=2):
• \- no detected voluntary grip or release function

You may not qualify if:

• Other neurological or musculoskeletal disease/injury, contagious disease or treatment with botulinum toxin in the upper extremity during the past 3 months.
• current or history of epilepsy, hearing problems, metal implants in the brain/skull cochlear implants, any implanted neurostimulator, cardiac pacemaker or cardiac implants of metal, infusion device.
• other neurological disorder, pregnancy, current or history of severe psychiatric disorder with need for pharmacological treatment

Sponsors & Collaborators

• Mälardalen University: lead
• Danderyd Hospital: collaborator
• Vinnova: collaborator

Study Sites (3)

Stockholn University Brain Imaging C entre

Stockholm, 11418, Sweden

Location

Department of rehabilitation medicine at Danderyd University

Stockholm, 18288, Sweden

Location

Mälardalen University

Västerås, 72123, Sweden

Location

Related Publications (4)

• Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a controlled study. Ann Neurol. 2013 Jul;74(1):100-8. doi: 10.1002/ana.23879. Epub 2013 Aug 7.

  PMID: 23494615 BACKGROUND

• Pichiorri F, Morone G, Petti M, Toppi J, Pisotta I, Molinari M, Paolucci S, Inghilleri M, Astolfi L, Cincotti F, Mattia D. Brain-computer interface boosts motor imagery practice during stroke recovery. Ann Neurol. 2015 May;77(5):851-65. doi: 10.1002/ana.24390. Epub 2015 Mar 27.

  PMID: 25712802 BACKGROUND

• Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22.

  PMID: 28003656 BACKGROUND

• Takemi M, Maeda T, Masakado Y, Siebner HR, Ushiba J. Muscle-selective disinhibition of corticomotor representations using a motor imagery-based brain-computer interface. Neuroimage. 2018 Dec;183:597-605. doi: 10.1016/j.neuroimage.2018.08.070. Epub 2018 Aug 30.

  PMID: 30172003 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elaine Astrand

  Mälardalen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: June 21, 2019
• Study Start: August 5, 2019
• Primary Completion: January 17, 2020
• Study Completion: January 17, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)