Brain State-dependent PCMS in Chronic Stroke

Launched by UNIVERSITY OF TEXAS AT AUSTIN · Mar 31, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to help people who have had a stroke regain some use of their hands. After a stroke, many individuals find it challenging to move their arms and hands due to damage in the brain. This study will test a method that combines brain and nerve stimulation to strengthen the connections in the brain that control hand movement. Researchers will compare the effects of this stimulation when given during specific times that are thought to be most effective, versus random times, to see which method works better for improving hand function.

To participate in this trial, you must be between the ages of 65 and 74 and have had a stroke more than six months ago, along with noticeable weakness in your arm. You should also be able to understand the study and give your consent to participate. If you qualify, you can expect to receive targeted brain and nerve stimulation, which may help improve your hand movement. It's important to note that certain medical conditions and a history of specific treatments may exclude you from participation, so be sure to discuss your medical history with the research team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • History of stroke \> 6 months ago
• • Presence of residual upper extremity hemiparesis
• • Willingness to participate
• • Ability to provide informed consent
• • Upper extremity Fugl-Meyer score \< 66
• • Mini Mental State Exam score \> 24
• • Discernible and reliable motor-evoked potential (MEP) elicited following single-pulse TMS to the lesioned hemisphere
• Exclusion Criteria:
• • History of neurological disease other than stroke
• • Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS), including: history of adverse reactions to TMS or PNS metal in head, eyes, neck, chest/trunk, or arms, including but not limited to shrapnel, surgical clips, fragments from metalworking, fragments from welding, implanted device, history of frequent and severe headaches or migraines, immediate family history of seizure or epilepsy, personal history of seizure or epilepsy, current, suspected, or planned pregnancy, current or recent (within the last 3 months) use of medications acting on the central nervous system other than selective serotonin reuptake inhibitors (SSRIs), including but not limited to antipsychotic drugs, benzodiazepines, prescription stimulants.
• • Upper extremity Fugl-Meyer score ≥ 66 (66 is the maximum on this scale)
• • Mini Mental State Exam score \<= 24
• • No discernible and reliable MEP elicited following single-pulse TMS to the lesioned hemisphere