fNIRS/HEG neurofeedback to improve hand function after stroke
Hand Rehabilitation in People With Hemiparesis After a Stroke Using 3D Imaging With fNIRS Neurofeedback
NA · University of Rzeszow · NCT07262528
This program will try adding HEG (fNIRS) neurofeedback to standard rehabilitation for adults 18–70 in the early subacute phase after a first ischemic stroke to improve hand and upper limb function.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Rzeszow (other) |
| Locations | 1 site (Rzeszów) |
| Trial ID | NCT07262528 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, single-blind interventional study enrolling 30 adults in the early subacute phase (≤3 months) after a first ischemic stroke with upper limb paresis (Brunnstrom stages 2–4). Participants are randomized 1:1 to standard rehabilitation or to standard rehabilitation supplemented with HEG/fNIRS neurofeedback using new hand-therapy software. During neurofeedback sessions patients focus on a presented task and when a predefined concentration threshold is reached the software triggers a virtual hand performing finger flexion to reinforce motor activation. Outcomes will compare hand and upper limb recovery between groups, with eligibility requiring age 18–70, MMSE >24, ability to sit independently, and no unstable medical or visual field conditions.
Who should consider this trial
Good fit: Adults aged 18–70 within three months of a first ischemic stroke who have upper limb paresis rated Brunnstrom 2–4, can sit independently, and have MMSE >24 are the intended candidates.
Not a fit: Patients with unstable medical conditions, visual field disorders, inability to sit independently, significant cognitive impairment (MMSE ≤24), or those beyond the subacute period (>3 months) are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, adding HEG/fNIRS neurofeedback could improve recovery of hand and finger movements beyond standard rehabilitation alone.
How similar studies have performed: Small pilot and early neurofeedback studies for post-stroke motor recovery have shown promising preliminary signals, but large randomized trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * individuals with hemiparesis after a first ischemic stroke, * subacute stroke period (no longer than 3 months), * upper limb paresis rated 2-4 by Brunnstrom recovery stages, * participants aged 18 to 70 years, * consent to participate in the study. Exclusion Criteria: * unstable general condition, * visual field disorders, * inability to sit independently, * cognitive impairment (Mini-Mental State Examination, MMSE \> 24).
Where this trial is running
Rzeszów
- University of Rzeszów — Rzeszów, Poland (RECRUITING)
Study contacts
- Study coordinator: Agnieszka Guzik
- Email: aguzik@ur.edu.pl
- Phone: +48 17 851 8965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke