Using brain-computer interface with TMS for stroke rehabilitation
Investigating the Use of a Brain-computer Interface Based on TMS Neurofeedback for Upper Limb Stroke Rehabilitation
This study is testing a new way to help stroke patients recover their arm movement by using a brain-computer interface and magnetic stimulation while they play a computer game that gives them feedback on their progress.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Dublin, Trinity College Academic / other |
| Locations | 1 site (Dublin, Leinster) |
| Trial ID | NCT06164912 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel approach to upper limb rehabilitation in stroke patients using a brain-computer interface (BCI) combined with transcranial magnetic stimulation (TMS). Participants will engage in a computer game designed to enhance their brain's recovery mechanisms by producing larger motor evoked potentials (MEPs) in their affected limb through mental imagery strategies. The game provides real-time neurofeedback based on the amplitude of MEPs, allowing patients to learn and improve their motor function. A control group will experience similar TMS procedures without the neurofeedback component to compare outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals in the sub-acute phase of stroke recovery with upper limb functional impairment and no significant cognitive deficits.
Not a fit: Patients with a history of neuromuscular or neurological diseases, or those with cognitive impairments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve upper limb function in stroke patients, enhancing their rehabilitation outcomes.
How similar studies have performed: While the use of TMS in stroke rehabilitation has been explored, this specific combination of BCI and neurofeedback is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be in the sub-acute phase (2-26 weeks) post stroke. 2. Single hemisphere lesion 3. No previous transient ischemic attack (TIA) 4. Upper limb functional impairment (0-2 power) 5. No or negligible OCS broken hearts test score (visual neglect) 6. No or almost no cognitive impairment (Pass or near pass MMSE and MOCA) 7. Passes TMS-Safety Questionnaire 8. Detectable motor evoked potential (MEP) in response to TMS The exclusion criteria include: * History of neuromuscular, neurological or active psychiatric disease (as these conditions and their respective medications may influence corticomotor excitability). * History of epilepsy or risk of reduced seizure threshold. There is a small remote risk of seizure associated with high-frequency repetitive TMS, which is NOT used in the current protocol. This study uses classical protocols and parameters that fall within the safety limits reported by Rossi et al (2009). Therefore this exclusion criteria is purely an additional precaution. * Presence of metallic implants in the head. The sole absolute contraindication to TMS is the presence of metallic implants near to the discharging coils. Exclusion is to avoid risk of heating, malfunction in the implanted device, or cause seizure. * History of anxiety-induced fainting. Patients with a history of anxiety induced fainting are at a small risk of fainting due to taking part in the study or hearing the 'clicking' sound produced by the TMS coil discharging. * History of reaction or allergy to equipment or the skin preparation gel used to clean the skin surface prior to placing EMG electrodes. While allergic reaction to any of the materials used us very unlikely, any participants with history of adverse reaction to the environments or materials used (or similar) will be excluded to protect their wellbeing and prevent distress. * Use of illicit drugs or other neurotransmission-altering drugs. These influence the brain and hence may impact upon the TMS or MRI measurements. * Consumption of alcohol on the night preceding the recordings- to avoid potential influence of residual alcohol on neural network activity. * Insufficient sleep on the night preceding the recording to prevent participants falling asleep or dozing during the recording, which would influence task performance. This is also in keeping with the guidelines of Rossi et al (2009). * Eating very little in the 6 hours preceding the study- to avoid weakness or faintness. * Any medical condition associated with neuropathy (eg.diabetes), seizure disorder, brain tumours, structural brain diseases, other degenerative brain diseases and other comorbidities (e.g human immunodeficiency virus). This is to prevent abnormal neural activity generating data related to something other than that of the diagnosis under study (stroke). * Any head trauma injury associated with loss of consciousness. * Regular, severe headaches * Noise induced hearing loss, or ringing in the ears. * Possible pregnancy * Implanted Neurostimulator * Anxiety in Hospital settings
Where this trial is running
Dublin, Leinster
- St James' Hospital — Dublin, Leinster, Ireland (Recruiting)
Study contacts
- Study coordinator: Kathy Ruddy, PhD
- Email: k.ruddy@qub.ac.uk
- Phone: +44 7481811676
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.