NCT05884762

Brief Summary

The aim of this study is to evaluate the effect of early rehabilitation treatment by electroencephalographic neurofeedback on upper limb motor function after stroke. Researchers will compare : Interventional group: electroencephalographic neurofeedback + traditional reference rehabilitation programme Control group: SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
18mo left

Started Feb 2024

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Feb 2024Nov 2027

First Submitted

Initial submission to the registry

May 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

May 23, 2023

Last Update Submit

February 26, 2026

Conditions

Stroke, IschemicStroke RehabilitationBrain InfarctionStrokeStroke Hemorrhagic

Keywords

StrokeRehabilitationneurofeedbackUpper Limb

Outcome Measures

Primary Outcomes (1)

  • Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity

    Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity

    28 days

Secondary Outcomes (18)

  • Changes in ACTIVE RANGE OF MOTION (CxA) composite score

    28 days

  • Changes in ACTIVE RANGE OF MOTION (CxA) composite score

    3 months

  • Changes in Action Research Arm Test (ARAT) score

    28 days

  • Changes in Action Research Arm Test (ARAT) score

    3 months

  • Changes in force emitted (in kg) during a palmar grip (JAMAR)

    28 days

  • +13 more secondary outcomes

Study Arms (2)

Interventional group

EXPERIMENTAL

electroencephalographic neurofeedback + traditional reference rehabilitation programme

Other: electroencephalographic neurofeedback

Control group

SHAM COMPARATOR

SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme

Other: SHAM electroencephalographic neurofeedback

Interventions

electroencephalographic neurofeedbackOTHER

The patient is installed in a quiet, isolated room in the Physical Medicine and Rehabilitation Department. The patient sits comfortably in front of a computer. A nurse or a rehabilitator installs the EEG headset and places gel in the electrodes (x32). Connecting the amplifier and interface. Checking the correct positioning and contact of the electrodes (impedance). * Calibration phase at rest. * Working phase: the sessions last 24 minutes. The patient will be asked to concentrate on the affected arm, and to imagine a movement of this arm, to feel the sensations, without any real movement of the arm. * In the Neurofeedback group, the patient will receive visual feedback of a virtual hand moving on a computer screen in front of him/her, depending on his/her brain activations. He will also receive haptic feedback (vibrations) in the flexor muscles of his wrist.

Interventional group
SHAM electroencephalographic neurofeedbackOTHER

The patient is installed in a quiet, isolated room in the Physical Medicine and Rehabilitation Department. The patient sits comfortably in front of a computer. A nurse or a rehabilitator installs the EEG headset and places gel in the electrodes (x32). Connecting the amplifier and interface. Checking the correct positioning and contact of the electrodes (impedance). * Calibration phase at rest. * Working phase: the sessions last 24 minutes. The patient will be asked to concentrate on the affected arm, and to imagine a movement of this arm, to feel the sensations, without any real movement of the arm. * In the SHAM group, the visual feedback and haptic feedback are randomly generated

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral ischaemic or haemorrhagic stroke
  • Adult (18-80 years), both sexes
  • Stroke \< 3 weeks
  • Upper limb deficit defined by Shoulder Abduction Finger Extension score \<5 measured during the 7 days following stroke; i.e., patients predicted to have incomplete recovery
  • No participation-limiting comprehension problems
  • With or without homonymous lateral hemianopia; with or without visuospatial hemineglect
  • Free, informed and written consent signed by the patient or a member of the patient's family (in the case of a patient who is able to understand the information and give consent but has motor difficulties resulting in an invalid signature).
  • Affiliated to french social security

You may not qualify if:

  • Ischemic or hemorrhagic brain stem and/or cerebellum involvement
  • Multiple strokes
  • Stroke \< 1 week; in order not to be deleterious by starting active rehabilitation too early after immediate stroke
  • Aphasia with major comprehension impairment
  • Contraindication to MRI
  • pacemaker or implantable defibrillator,
  • neurosurgical clips,
  • cochlear implants,
  • intra-orbital or encephalic metallic foreign bodies,
  • stents placed less than 4 weeks ago and osteosynthesis devices placed less than 6 weeks ago,
  • claustrophobia. (Patients who have undergone thrombolysis or thrombectomy may be included in the study.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes Chu

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

StrokeHemorrhagic StrokeIschemic StrokeBrain Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Simon BUTET, MD

    Rennes CHU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LOÏC JACOB

CONTACT

0299282555loic.jacob@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The occupational therapist who will include and do the sessions will be open. The assessors who will test motor functions during the assessments will be blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 1, 2023

Study Start

February 20, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

FR(1)