Amplitude Modulation Frequency Comparison in Kilohertz Transcranial Magnetic Perturbation (kTMP) for Chronic Stroke
Studieoversigt
Detaljeret beskrivelse
The goal of this study is to test the feasibility of a novel first-in-class non-invasive approach to enhance motor function in stroke patients. This study has a crossover design comparing low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude modulation in kTMP on upper extremity kinematics in chronic stroke patients. The kilohertz Transcranial Magnetic Perturbation (kTMP) device allows the investigators to target frequency-specific neural activity non-invasively - with no patient discomfort - at and beyond stimulation intensities associated with enhanced recovery from stroke (up to 8 V/m), something that is not possible to achieve with existing NIBS methods.
The trial also aims to assess the short-term effects of kTMP on reach-to-grasp kinematics. kTMP stimulation is targeted to the motor hotspot for eliciting motor evoked potentials (MEPs) within motor cortex to evaluate short term changes in motor performance.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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Berkeley, California, Forenede Stater, 94704
- Magnetic Tides Inc.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Adults aged 18-80 years who have a history of a unilateral stroke ≥ 12 m prior to enrollment.
- Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-55.
- Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands.
- Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive).
Exclusion Criteria:
- Participants with moderate or severe cognitive impairment (MoCA < 18).
- Participants with sensory deficits FMA-S ≥ 6/12 (with proprioception ≥ 2/4).
- Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.
- Individuals who have a serious uncontrolled medical condition, including but not limited to severe cardiovascular and cardiopulmonary disease.
- Pregnancy or plans to become pregnant during the study period.
- Botulinum toxin injections of the affected upper extremity within 3 months prior to onset of study assessments/testing through the last visit.
- Severe spasticity of the affected upper limb (Modified Ashworth ≥ 3).
- Absolute contraindications related to non-invasive brain stimulation, including:
History of seizures in the last 12 months while taking anti-epilepsy medication Presence of any metal implants in the head (excluding the mouth), such as cortical stimulators and DBS, clips, coils, shunts, stents or skull plates, cochlear implants Permanent eye liner or head tattoos Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator History of experiencing a serious adverse event during a previous transcranial magnetic stimulation (TMS) session
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Stimulation Condition A
Active kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude
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Et nyt ikke-invasivt hjernestimuleringsværktøj
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Eksperimentel: Stimulation Condition B
Active kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude
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Et nyt ikke-invasivt hjernestimuleringsværktøj
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Reach-to-grasp (Range of Motion)
Tidsramme: 3 weeks
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Defined as the standard deviation of the joint angle time series for a given trial.
The average will be computed over a set of 15 trials.
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3 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Fugl- Meyer Assessment (Upper Extremity)
Tidsramme: 3 weeks
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A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment.
It is graded from 0 (hemiplegia) to 66 for the Upper extremity.
Higher scores signifies better motor control, and hence a better outcome.
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3 weeks
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Modified Ashworth Scale (MAS)
Tidsramme: 3-weeks
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Clinical tool for measuring muscle spasticity and increased muscle tone.
The MAS is a 6-point scale (0, 1, 1+, 2, 3, 4) measuring spasticity from no increase in tone to rigid limbs.
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3-weeks
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Magnetic Tides Inc
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med kTMP
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Magnetic TidesNational Institute of Neurological Disorders and Stroke (NINDS); University...RekrutteringSlag | Armsvaghed som en konsekvens af slagtilfælde | Patienter med kronisk slagtilfældeForenede Stater
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Magnetic TidesTilmelding efter invitation
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University of California, San FranciscoNational Institute of Neurological Disorders and Stroke (NINDS)Ikke rekrutterer endnuSlag | Armsvaghed som en konsekvens af slagtilfælde | Patienter med kronisk slagtilfældeForenede Stater
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Magnetic TidesUniversity of California, BerkeleyAfsluttet