Brain Computer Interface Training After Stroke | NCT04071587

Studies
Brain Computer Interface Training After Stroke

NCT04071587

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Nov 14, 2022Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Stroke

Interventions

Brain Computer Interface training
Control

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 26, 2019Actual

Primary Completion Date

Mar 31, 2022Actual

Completion Date

Mar 31, 2022Actual

First Submitted Date

Aug 21, 2019

First Submission Date that Met QC Criteria

Aug 27, 2019

First Posted Date

Aug 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2022

Last Update Posted Date

Nov 14, 2022Actual

Name	Class
Hammel Neurorehabilitation Centre and University Research Clinic	OTHER
Sygekassernes Helsefond	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

A randomized controlled pilot study will be conducted. Forty patients with severe UL paresis will be included. Patients with severe hemiparesis after stroke will be allocated to one of two treatment groups by a computerized randomization program. Patients in the intervention group will receive training with a BCI system paired with functional electrical stimulation and visual feedback (RecoveriX, gtec, Austria) as part of their rehabilitation. The targeted number of training sessions in the intervention group is 12. Patients in the control group will receive conventional upper limb training. All patients will receive other rehabilitation according to their needs.

Patients will be assessed by blinded raters before and after the intervention and 3 months post stroke. Main endpoint will be UL motor function assessed by Action Research Arm Test (ARAT) at 3 months post stroke. Other outcome measures comprise Fugl Meyer Motor Assessment and Functional Independence Measure. The patients and therapists' experience with this type of training will be evaluated with questionnaires and interviews.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Brain Computer Interface training	Device	Training with RecoveriX system.	BCI training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Action Research Arm Test (ARAT)	Upper limb function on a scale of 0 - 57 (best)	Upper limb function 90 days after stroke

Secondary Outcomes

Measure	Description	Time Frame
Fugl-Meyer Assessment (UL)	Upper limb impairment on a scale from 0-66 (best)	Upper limb impairment 90 days after stroke
Functional Independence Measure	Independence in activities og daily living, 18-126 (best)

Other Outcomes

Measure	Description	Time Frame
Interviews	Qualitative assessment of user experiences	Through study completion, an average of 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First ever or former stroke without UL motor residuals as confirmed by CT and / or MRI
15 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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iris Brunner, PhD	Aarhus University, Hammel Neurocenter	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hammel Neurorehabilitation Centre and University Research Clinic		Hammel	Aarhus	8450	Denmark

Type	Date	Date Unknown
Release	May 8, 2024
Reset	Sep 18, 2024

Submission Tracking

Estimated Results First Submitted Date

May 8, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 8, 2024			Sep 18, 2024

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D010291	Paresis

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided