Brain Computer Interface Training After Stroke

NCT04071587 | Completed DMC

• 1 other identifier: 649780
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we want to examine the effect of a new treatment approach for patients with severe upper limb paresis in the subacute phase after stroke. Brain Computer Interface (BCI) driven functional electrical stimulation will be compared to conventional training.

Conditions

Stroke

Keywords

BCI; upper limb; severe paresis; subacute stroke; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test (ARAT)

  Upper limb function on a scale of 0 - 57 (best)

  Upper limb function 90 days after stroke

Secondary Outcomes (2)

• Fugl-Meyer Assessment (UL)

  Upper limb impairment 90 days after stroke

• Functional Independence Measure

  Functional independence 90 days after stroke

Other Outcomes (1)

• Interviews

  Through study completion, an average of 6 months

Study Arms (2)

BCI training

EXPERIMENTAL

Patients randomized to this group will receive up to12 (minimum 8) sessions of BCI training with the RecoveriX system (gtec, Austria). The system combines EEG driven functional electrical stimulation with visual feedback. BCI training is provided as a part of standard training of the impaired upper limb.

Device: Brain Computer Interface training

Control

ACTIVE COMPARATOR

Patients randomized to this control group will receive standard physiotherapy and occupational therapy for their impaired upper limb.

Behavioral: Control

Interventions

Brain Computer Interface training DEVICE

Training with RecoveriX system.

BCI training

Control BEHAVIORAL

Standard physiotherapy and occupational therapy according to clinical routines.

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First ever or former stroke without UL motor residuals as confirmed by CT and / or MRI
• days to 60 days (+/- 3) after stroke onset
• Severe paresis or paralysis defined as \< 13 on Action Research arm Test (ARAT)
• Able to give informed consent
• Able to comply with treatment protocol.

You may not qualify if:

• Other conditions limiting functional use of the affected UL,
• Psychiatric / behavioral conditions that interfere with compliance to the protocol, epilepsy

Sponsors & Collaborators

• University of Aarhus: lead
• Hammel Neurorehabilitation Centre and University Research Clinic: collaborator
• Sygekassernes Helsefond: collaborator

Study Sites (1)

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Aarhus, 8450, Denmark

Location

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

• Iris Brunner, PhD

  Aarhus University, Hammel Neurocenter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All assessments will be done by assessors blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomized to one of two treatment options, intervention or standard rehabilitation

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: August 26, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-01

Locations

DK (1)