Stroke Therapy With Brain Oscillation Synchronized Stimulation
Germany30 participantsStarted 2019-10-02
Plain-language summary
This randomized, controlled, double-blind clinical pilot trial investigates the therapeutic potential of a novel personalized therapeutic brain-stimulation protocol in chronic stroke patients with spasticity. Stroke patients will either receive ipsilesional 100 Hz transcranial magnetic stimulation (TMS) triplet burst protocol synchronized to the ongoing µ-alpha oscillation or contralesional 1 Hz repetitive TMS (rTMS) protocol. Motor recovery is assessed directly after as well as three months after completion of the therapy.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients are between 18 to 85 years old
✓. Patient suffers from chronic stroke including hand/arm paresis and spasticity
✓. Ipsilesional motor evoked potentials (MEPs) can be evoked (EMG \> 50uV)
✓. RMT of contralesional side \< 70% maximum stimulator output (MSO)
✓. Patient is willing to comply with the study restrictions.
✓. Subject FMA-UE at the lesioned side is \<= 60.
Exclusion criteria
✕. Patient is under the age of legal consent.
✕. Patient has a history of seizure disorder.
✕. Patient with intake of pro-convulsive medication, e.g. , chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, MDMA (ecstasy), phencyclidine (PCP, angel's dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline, in accord with present consensus guidelines on safety, ethical considerations, and application of TMS in clinical practice and research (Rossi et al., 2009, 2021).
✕. Subject with intake of muscle-relaxing medication (e.g. baclofen, tizanidine, gabapentin,tolperisone, THC and derivates)
✕. When spasticity is treated with botox there have to be at least tree months since the last injection
✕. Patient has a cardiac pacemaker, implanted medication pump, intracardiac line, that is located close to (≤ 10 cm) to the location of activation of the TMS coil or acute, unstable cardiac disease.
What they're measuring
1
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Timeframe: Difference of score directly before intervention and score directly after intervention
2
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Timeframe: Difference of score directly before intervention and score 3 months after intervention
✕. Patient has an intracranial implant (e.g., aneurysm clips, shunts, stimula-tors, cochlear implants, or electrodes) or any other metal object that is located close to (≤ 10 cm) to the location of activation of the TMS coil (excluding the mouth) and that cannot be safely removed.
✕. Patient has participated in another study within 2 weeks prior to the first study visit.