Trial results for a study investigating a novel brain stimulation approach for severe stroke were posted on 2025-06-05, involving 16 participants. The study reported mean changes in several upper limb motor function and neurophysiology measures.
Background
Stroke can lead to significant and severe limitations in the use of affected upper limbs, posing a major challenge for rehabilitation. Current therapeutic approaches aim to restore motor function, but severe cases often require innovative interventions. This study explored a novel method of non-invasive brain stimulation combined with upper limb training, with the long-term goal of developing effective rehabilitation strategies for stroke survivors with severe upper limb impairments.
Trial design
This completed study, designated as Phase EARLY_PHASE1, enrolled 16 participants diagnosed with Stroke. The trial investigated a novel method of non-invasive brain stimulation, specifically repetitive transcranial magnetic stimulation (rTMS), in conjunction with upper limb training. The intervention was administered over 12 visits across a 6-week period. Participants were divided into two groups: those receiving cPMD rTMS + Training and those receiving iM1 rTMS + Training.
Key results
The trial reported several key measurements related to changes from baseline to post-test:
- Change in Upper Extremity Fugyl-Meyer Score (UEFM) (change score from baseline to post-test):
- For the cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was 2.625 (Standard Error 0.498).
- For the iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was 2.625 (Standard Error 0.680).
- Change in Inter-hemispheric Inhibition (IHI) (milliseconds):
- For the cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was -8.8774 (Standard Error 4.62765).
- For the iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was 3.04521 (Standard Error 4.62765).
- Change in Wolf Motor Function Test (WMFT) Functional Ability (units on a scale):
- For the cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was 0.083 (Standard Error 0.047).
- For the iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was 0.217 (Standard Error 0.077).
- Change in Wolf Motor Function Test (WMFT) Rate Paretic Limb (Tasks per minute):
- For the cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was 0.970 (Standard Error 0.682).
- For the iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was 2.972 (Standard Error 1.165).
- Change in Wolf Motor Function Test (WMFT) Rate Non-paretic Limb (Tasks per minute):
- For the cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was 2.552 (Standard Error 1.048).
- For the iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was 3.098 (Standard Error 0.977).
- Change in Wolf Motor Function Test (WMFT) Rate Paretic Limb Normalized to the Non-paretic Limb (Tasks per minute):
- For the cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was 1.593 (Standard Error 1.477).
- For the iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training group, the mean change was 2.921 (Standard Error 1.306).
What this means
This early-phase trial provides initial data on the effects of a novel non-invasive brain stimulation approach combined with upper limb training in a small cohort of stroke survivors with severe limitations. The reported mean changes in measures such as the Upper Extremity Fugyl-Meyer Score and Wolf Motor Function Test indicate observed improvements in motor function and neurophysiology. While these findings are preliminary and from a small sample size, they contribute to understanding the potential of such interventions for rehabilitation in severe stroke, warranting further investigation in larger studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03868410, titled "A Novel Approach for Brain Stimulation in Severe Stroke", were posted on 2025-06-05 on clinicaltrials.gov.