Investigating the Use of a Brain-computer Interface Based on TMS Neurofeedback for Upper Limb Stroke Rehabilitation

Launched by UNIVERSITY OF DUBLIN, TRINITY COLLEGE · Dec 6, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people recover movement in their arms after a stroke. The study is using a technique called Transcranial Magnetic Stimulation (TMS), which sends magnetic pulses to the brain to stimulate areas that may have been damaged by the stroke. This stimulation can cause small twitches in the arm muscles, which are shown on a computer screen as part of a game. The goal is for patients to learn how to make these twitches bigger by using their imagination to help re-activate the affected part of their brain.

To participate in this trial, individuals should be between 65 and 74 years old and have experienced a stroke within the last 2 to 26 weeks that has affected one side of their body. They should also have limited movement in their arm and no significant cognitive issues. Participants will engage in the TMS sessions and play the neurofeedback game, helping them practice and potentially improve their arm movement. It’s important to note that certain medical conditions and histories may prevent someone from joining the study, such as having a metal implant in the head or a history of seizures. This study aims to find out how effective this technique can be in aiding recovery for stroke patients.

Gender

ALL

Eligibility 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