Early Phase 1
N=16
A Novel Approach for Brain Stimulation in Severe Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03868410 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Upper Extremity Fugyl-Meyer Score (UEFM) — 2.625; 2.625 change score from baseline to post-test
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- New Repetitive Magnetic Stimulation (rTMS) Approach (Device); Conventional Repetitive Magnetic Stimulation (rTMS) Approach (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Upper Extremity Fugyl-Meyer Score (UEFM) |
2.625; 2.625 | — |
| PRIMARY Change in Inter-hemispheric Inhibition (IHI) |
-8.8774; 3.04521 | — |
| SECONDARY Change in Wolf Motor Function Test (WMFT) Functional Ability |
0.083; 0.217 | — |
| SECONDARY Change in Wolf Motor Function Test (WMFT) Rate Paretic Limb |
0.970; 2.972 | — |
| SECONDARY Change in Wolf Motor Function Test (WMFT) Rate Non-paretic Limb |
2.552; 3.098 | — |
| SECONDARY Change in Wolf Motor Function Test (WMFT) Rate Paretic Limb Normalized to the Non-paretic Limb |
1.593; 2.921 | — |
| SECONDARY Change in Stroke Impact Scale (SIS-16) |
4.250; 1.375 | — |
| SECONDARY Change Resting State Functional Magnetic Resonance Imaging(rsfMRI) |
— | — |
| SECONDARY Change in Ipsilateral MEPs (Motor Evoked Potentials) |
— | — |
| SECONDARY Diffusion Tensor Imaging (DTI) |
— | — |
| SECONDARY Change in SULCS |
— | — |
Summary
The long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for stroke survivors, specifically survivors with more severe limitations in use of their affected upper limb.
This study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 12 visits over a period of 6 weeks.
The study will include the following site visits:
* Eligibility Screening and Informed Consent Visit
* An MRI visit
* Two testing visits in which motor function of the upper limb and neurophysiology will be measured
* 12 intervention visits during which patients will receive upper limb training in conjunction with non-invasive brain stimulation
* Repeat testing of motor function of the upper limb and neurophysiology
* Repeat MRI testing
* A follow-up visit completed 3 months after the completion of interventions
Eligibility Criteria
Inclusion Criteria
- chronic phase (≥6 months) after index stroke
- moderate or severely impaired (UEFM ≤42)
- have either extensive damage to ipsilesional pathways (MEP-), or, have one of the following: less than 10 degrees active wrist extension, less than 10 degrees active thumb extension/abduction, less than 10 degrees active extension in at least 2 additional digits (i.e. will not meet minimum Constraint-Induced Movement Therapy [CIMT] criteria).
- medically stable
Exclusion Criteria
- cerebellar stroke
- brainstem stroke
- bilateral strokes affecting sensorimotor structures
- severe cognitive impairment
- substantially elevated tone/spasticity in wrist/hand (Modified Ashworth Scale >3)
- severe contracture
- participation in outpatient or Botox therapy within 2 months
- exclusion criteria for TMS and MRI (metal implant in head, H/O seizures, alcohol or substance abuse, intake of medications contraindicated with TMS, cardiac pacemaker or programmable implant).
Data sourced from ClinicalTrials.gov (NCT03868410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.