TMS for Stroke Recovery
Trial Summary
What is the purpose of this trial?
Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal tract (CST) connections and promote poststroke hand motor recovery. To maximize the effects of such interventions, they must be delivered during brain activity patterns during which TMS best activates the residual CST and enhances its neural transmission. This approach is termed brain state-dependent TMS. The investigators have recently developed a machine learning framework that identifies personalized brain activity patterns reflecting strong CST activation in neurotypical adults. In this study, the investigators will apply this framework to the poststroke brain for the first time. They will also evaluate relationships between this framework's ability to detect strong and weak CST activation states and measures of CST pathway integrity. Participants will visit the laboratory for two days of testing that are separated by at least one night of sleep. On Day 1, participants will provide their informed consent. The MacArthur Competence Assessment Tool and the Frenchay Aphasia Screening Test will be used to evaluate consent capacity and confirm the presence of expressive aphasia as needed. Afterwards, participants will complete eligibility screening and clinical assessment of upper extremity motor impairment, motor function, and disability using the Upper Extremity Fugl-Meyer Assessment, the Wolf Motor Function Test, and the Modified Rankin Scale. Participants will then be screened for the presence of residual CST connections from the lesioned hemisphere to the affected first dorsal interosseous muscle. Recording electrodes will be attached to this muscle in order to record TMS-evoked twitches in these muscles. During this procedure, single-pulse TMS will be applied to each point of a 1 cm resolution grid covering primary and secondary motor areas of the lesioned hemisphere at maximum stimulator output. If TMS reliably elicits a muscle twitch in the affected first dorsal interosseous, that participant will be considered to have residual CST connections and will be eligible for the full study. If no muscle twitch is observed, the participant will not be eligible for the full study. Afterwards, recording electrodes will be removed and the participant will leave the laboratory. On Day 2, participants will return to the laboratory. The investigators will confirm continued eligibility and place recording electrodes on the scalp using a swim-type cap. The investigators will also place recording electrodes on the affected first dorsal interosseous as well as the affected abductor pollicis brevis and extensor digitorum communis muscles. After identifying the scalp location at which TMS best elicits muscle twitches in the affected first dorsal interosseous muscle, the investigators will determine the lowest possible TMS intensity that such evokes muscle twitches at least half of the time. Then, the investigators will deliver 6 blocks of 100 single TMS pulses while participants rest quietly with their eyes open. Stimulation will be delivered at an intensity that is 20% greater than the lowest possible TMS intensity that evokes muscle twitches at least half the time. Afterwards, all electrodes will be removed, participation will be complete, and participants will leave the laboratory. The investigators will recruit a total of 20 chronic stroke survivors for this study.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that any recent changes to medication use within the last month may affect eligibility. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment TMS for stroke recovery?
Is Transcranial Magnetic Stimulation (TMS) safe for humans?
Transcranial Magnetic Stimulation (TMS), including its variations like repetitive TMS (rTMS) and theta burst stimulation (TBS), is generally considered safe for humans, with most adverse events being mild. However, there is a small risk of seizures, especially with TBS, so it should be used with caution and under professional supervision.46789
How is the treatment TMS for stroke recovery different from other treatments?
Eligibility Criteria
This trial is for chronic stroke survivors who still have some connection between their brain and hand muscles, as shown by muscle twitches in response to TMS. They must be able to give informed consent, which may involve passing tests if they have speech difficulties due to the stroke.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Testing
Participants undergo initial testing including informed consent, eligibility screening, and clinical assessment of motor impairment
TMS Intervention
Participants receive TMS intervention to identify brain activity patterns and determine TMS intensity for muscle twitch elicitation
Follow-up
Participants are monitored for safety and effectiveness after intervention
Treatment Details
Interventions
- Transcranial Magnetic Stimulation (TMS)
Transcranial Magnetic Stimulation (TMS) is already approved in United States, European Union for the following indications:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
- Migraine Headache Symptoms
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas at Austin
Lead Sponsor
Emory University
Collaborator