iTMS - Implementing Transcranial Magnetic Stimulation (TMS) to Assess Cortico-spinal Tract Integrity

NCT06153017 | Active Not Recruiting

• 1 other identifier: iTMS786101
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Reliable prediction of upper limb (UL) function can guide clinicians in choosing relevant treatment, helps to set realistic goals for rehabilitation and will contribute to personalized and effective rehabilitation. TMS has been identified as a strong predictor of future UL function after stroke. With this project, the investigators want to implement the standard use of TMS examination for a defined patient group in the clinical setting and systematically evaluate the implementation process. The impact and perceived value of TMS in the clinical setting will be evaluated and the predictive value of TMS for the specific patient population will be assessed.

Conditions

Stroke

Keywords

Transcranial Magnetic Stimulation; Upper limb function; Stroke; Neurorehabilitation; Implementation; Biomarker

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test

  Assesses arm motor function, range 0-57 (best)

  3 months after stroke

Secondary Outcomes (2)

• Shoulder Abduction Finger Extension Test

  3 months after stroke

• Fugl-Meyer Motor Assessment Upper Limb (0-66 best)

  3 months after stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We include patients with stroke and severe paresis or paralysis of an upper limb after stroke.

You may qualify if:

• admitted to rehabilitation within 21 days after stroke
• severe UL impairment, either paralysis (no active movement), or severe paresis, defined as Fugl-Meyer Assessment \<17 or Shoulder Abduction Finger Extension (SAFE) score \< 5
• At least 18 years old
• able to provide informed consent and comply with examination procedures

You may not qualify if:

• Epilepsy
• Metal implants in the head
• Other implanted electronics (cardiac pacemaker, defibrillator, cochlear implant, medication pump)
• Skull fracture or serious head injury
• Pregnancy

Sponsors & Collaborators

• University of Aarhus: lead
• Hammel Neurocenter University Hospital and Research Clinic: collaborator

Study Sites (1)

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Aarhus, 8450, Denmark

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, associate professor

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: December 1, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

DK (1)