kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot
kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The goal of this pilot clinical trial is to assess the feasibility and preliminary efficacy of kTMP on upper limb motor recovery in chronic stroke compared to sham. We will conduct a 6-week double-blind, randomized, sham-controlled pilot study to test the beneficial influence of kTMP combined with simple motor tasks on kinematic outcomes such as range of motion of the upper arm, hand and fingers.
After baseline assessments, participants will be randomly allocated to either the kTMP group or the Control group. Participants, experimentalists, and outcome assessors will be blinded to group allocation. kTMP will begin within 1 week following randomization and will be delivered three times a week for 6 weeks. The primary endpoint will be assessed at the end of treatment, with follow-up assessments occurring 1 month, 3 months and 6 months following treatment completion. There is one assessment 4 weeks into the treatment phase to assess if patients continue to improve from 4 to 6 weeks of treatment.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ludovica Labruna, PhD
- Telefonnummer: 5104237125
- E-post: participate@magnetictides.com
Studiesteder
-
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California
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San Francisco, California, Forente stater, 94158
- Rekruttering
- UCSF Mission Bay- Sandler Neurosciences Center
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Ta kontakt med:
- Christina Merrick
- Telefonnummer: 510-423-7125
- E-post: participate@magnetictides.com
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Hovedetterforsker:
- Ludovica Labruna, PhD
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Hovedetterforsker:
- Richard Ivry, PhD
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Hovedetterforsker:
- Karunesh Ganguly, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion criteria:
- Adults aged 18-80 years who have a history of an ischemic or hemorrhagic stroke ≥ 12 m prior to enrollment.
- Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50.
- 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 < 4/8).
- Participants with severe apraxia (TULIA < 5).
- 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.
- Severe spasticity of the affected upper limb (Modified Ashworth ≥ 4).
- Absolute contraindications related to non-invasive brain stimulation, including:
9a) History of seizures in the last 12 months while taking anti-epilepsy medication 9b) 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 9c) Permanent eye liner or head tattoos 9d) Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator 9e) History of experiencing a serious adverse event during a previous transcranial magnetic stimulation (TMS) session
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Aktiv KTMP
Deltakerne fikk 8 V/M aktiv stimulering
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Et nytt ikke-invasivt hjernestimuleringsverktøy
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Sham-komparator: Sham kTMP
Participants receive sham stimulation (0.0 V/m electric field)
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Et nytt ikke-invasivt hjernestimuleringsverktøy med falsk innstilling valgt
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Range of Joint Motion (ROM)
Tidsramme: 6 weeks
|
defined as the standard deviation of the joint angle time series for a given trial.
The median ROM will be calculated for eleven degrees of freedom and then averaged.
If there are joints which appear to be compensatory, they will be removed from the analysis
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6 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fugl- Meyer Assessment (Upper Extremity)
Tidsramme: 6 weeks
|
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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6 weeks
|
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Modified Ashworth Scale (MAS)
Tidsramme: 6 weeks
|
Used to measure spasticity in wrist and hand flexors and extensors.
It assigns a grade of spasticity from 0-4.
Lower scores represent normal muscle tone and higher scores represent spasticity.
Hence lower scores are associated with better outcomes.
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6 weeks
|
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Transport Time
Tidsramme: 6 weeks
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Calculated for each of three epochs, pre, during and post
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6 weeks
|
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Trial to Trial Variability (T2TV)
Tidsramme: 6 weeks
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Defined as the mean-squared error between the joint angle time-series for a given trial and the median joint angle timeseries.
The median T2TV will be calculated for eleven degrees of freedom.
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6 weeks
|
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Grasp to Lift Time
Tidsramme: 6 weeks
|
Calculated for each of three epochs, pre, during and post
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6 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- Slag
- Transkraniell magnetisk stimulering
- Iskemisk hjerneslag
- Ikke-invasiv hjernestimulering
- Kortikal eksitabilitet
- Kronisk hjerneslag
- Plastisitet
- Cerebrovaskulære lidelser
- Hjernelidelser
- Forstyrrelser i sentralnervesystemet
- Hemorragisk slag
- Kardiovaskulære lidelser
- kTMP
- kilohertz transkraniell magnetisk forstyrrelse
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- kTMPstrokePilot
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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