Prognostic model for recovery after stroke

Neural Network Reorganization Associated With Upper Limb Motor Recovery in Stroke Patients- Establishing a Prognostic Model and Tailoring Neuromodulation for Rehabilitation

This study is trying to see if certain brain tests can help predict how well stroke patients will recover their arm movement and if brain stimulation can improve their recovery based on their individual brain patterns.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: National University Hospital, Singapore (other)
• Locations: 2 sites (Singapore and 1 other locations)
• Trial ID: NCT05332652 on ClinicalTrials.gov

What this trial studies

This study investigates neurophysiological changes following a stroke and their relationship with upper limb motor recovery. It aims to establish a prognostic model using biomarkers from transcranial magnetic stimulation (TMS), high density electroencephalography (HD-EEG), functional magnetic resonance imaging (fMRI), and Diffusion Tensor Imaging (DTI). The study includes a longitudinal cohort of stroke patients and a control group of healthy subjects, assessing motor function recovery over time. Additionally, it explores the efficacy of non-invasive brain stimulation techniques to enhance recovery outcomes tailored to individual neural patterns.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-80 who have experienced their first stroke within the last 6 weeks and have moderate to severe upper limb impairment.

Not a fit: Patients with conditions such as pregnancy, significant medical contraindications, or those with terminal diagnoses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery strategies for stroke patients, enhancing their upper limb motor function.

How similar studies have performed: Other studies have shown promise in using neurophysiological markers for stroke recovery, but this specific combination of approaches is relatively novel.

Eligibility criteria

* Inclusion criteria for stroke patients:

  1. 21-80 years old;
  2. First ever stroke less than 6 weeks;
  3. Moderate to severe upper limb impairment with Manual Muscle Testing (MMT) score on shoulder abduction plus finger extension (SAFE) \<5 within the first week post-stroke.
* Inclusion criteria for healthy subjects:

  1. Age 21-80 years old;
  2. No known medical history.
* Exclusion criteria for stroke patients:

  1. Pregnancy;
  2. Any metal implants inside the body that are contraindications of MRI scan;
  3. cardiac pacemakers;
  4. History of epilepsy;
  5. Sensorimotor disturbance due to other causes other than stroke;
  6. Claustrophobia;
  7. Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
  8. Major depression and a history of psychotic disorders;
  9. Terminal diagnosis with life expectancy \<=1 year.
* Exclusion criteria for healthy subjects:

  1. Pregnancy;
  2. Any metal implants inside the body that are contraindications of MRI scan;
  3. cardiac pacemakers;
  4. Claustrophobia.

Where this trial is running

Singapore and 1 other locations

• Alexandra Hospital — Singapore, Singapore (RECRUITING)
• National University Hospital — Singapore, Singapore (RECRUITING)

Study contacts

• Principal investigator: Effie Chew, MBBS — National University Hospital, Singapore
• Study coordinator: Effie Chew, MBBS

Conditions: Stroke, Acute, stroke, motor recovery, prognostic model, transcranial magnetic stimulation, transcranial direct current stimulation, neuromodulation