Individualized Neuro-Modulation Paired With Cerebellar Therapy (IMPACT)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Cerebellar damage causes debilitating ataxia affecting balance, coordination, speech, and cognition. Rehabilitation therapy is the main treatment for ataxia because pharmacological therapeutics are extremely limited. Non-invasive brain stimulation has shown promise in improving motor function and has an excellent safety profile. However, optimal stimulation sites and efficacy when combined with rehabilitation remain unclear.
We hypothesize that three weeks of intensive rehabilitation therapy paired with personalized transcranial direct current stimulation (tDCS) will produce greater functional improvements in people with cerebellar damage compared to therapy with sham stimulation.
This double-blind, randomized, sham-controlled trial will enroll participants with cerebellar damage. We will determine stimulation sites using multimodal neuroimaging and electric field modeling and then check their response to stimulation. If they show MRI response to stimulation and it is well-tolerated, they will be eligible to receive 30 hours of training (one hour, twice daily), with active or sham tDCS during one of the daily sessions Primary outcomes are the Scale for Assessment and Rating of Cerebellar Ataxia (SARA) and Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia), assessed pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
This research addresses a critical gap in treatment options for cerebellar ataxia by testing whether personalized neuromodulation enhances rehabilitation outcomes.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Anthony J Gonzalez, BS
- Telefonnummer: 443-923-2716
- E-post: gonzalezan@kennedykrieger.org
Studer Kontakt Backup
- Navn: Derek J Eversley, BS
- Telefonnummer: 443-923-2716
- E-post: eversley@kennedykrieger.org
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater, 21205
- Rekruttering
- Motion Analysis Lab in the Kennedy Krieger Institute
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Ta kontakt med:
- Anthony J Gonzalez, BS
- Telefonnummer: 443-923-2716
- E-post: gonzalezan@kennedykrieger.org
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Hovedetterforsker:
- Amy J Bastian, PhD, PT
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age 18-75 years
- Males and Females
- Disorders that predominantly affect the cerebellum: damage from stroke, tumor or degeneration (genetic or non-genetic causes, congenital hypoplasia).
Exclusion Criteria:
- Diagnoses or impairments that interfere with task execution or data interpretation.
- Heart pacemaker or other MRI-incompatible implanted metal device
- Metallic foreign body in their eye or head
- Experience with severe claustrophobia
- Experience discomfort from the MRI scan, such as excessive heating of tattoos
- Seizures or history of seizure disorder
- Alcohol or substance use disorder (self-report)
- Diagnosed history of severe psychiatric disorder such as depression, schizophrenia (self-report)
- Metallic foreign body in their eye or head (except the mouth e.g. dental fillings)
- Specific medications: tricyclic anti-depressants or neuroleptic medication
- Any medical condition (including orthopedic, pain, cardiopulmonary or other) that limits safe participation in exercise training
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Active stimulation combined with therapy.
Once a stimulation site is determined, subjects will receive 20 minutes of active tDCS stimulation daily.
Subjects will also receive one hour of therapy, twice daily.
Therapy will be individualized to each subject and, will encompass three domains; 1) walking and balance control, 2) hand dexterity and arm control, 3)speech articulation, prosody, and intelligibility.
Subjects will complete up to 30 therapy sessions.
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Each participant will choose a domain that they would like to focus on.
Choices are: 1) walking and balance control, 2) hand dexterity and arm control, or 3) speech articulation, prosody, and intelligibility.
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Sham-komparator: Sham stimulation combined with therapy.
Once a stimulation site is determined, subjects will receive 20 minutes of sham tDCS stimulation daily.
Subjects will also receive one hour of therapy, twice daily.
Therapy will be individualized to each subject and, will encompass three domains; 1) walking and balance control, 2) hand dexterity and arm control, 3)speech articulation, prosody, and intelligibility.
Subjects will complete up to 30 therapy sessions.
|
Each participant will choose a domain that they would like to focus on.
Choices are: 1) walking and balance control, 2) hand dexterity and arm control, or 3) speech articulation, prosody, and intelligibility.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Scale for the Assessment and Rating of Ataxia (SARA)
Tidsramme: Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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The SARA is a tool for assessing ataxia.
SARA is an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).
The scores are based on patient performance of: gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements, heel-shin slide.
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Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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Patient-Reported Outcome Measure of Ataxia
Tidsramme: Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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The PROM-Ataxia is a self reported questionnaire used by researchers to evaluate the daily impact and progression of cerebellar ataxia directly from the patient's perspective.
The questionnaire encompasses 70 total items within 3 main domains: 1) Physical: Gait, manual dexterity, swallowing (dysphagia), and visual/ocular motor control.
2) Activities of Daily Living (ADL): Managing household chores, employment, driving, and self-care.
3)Mental: Mood, anxiety, motivation, and cognitive tasks (e.g., multitasking and comprehension).
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Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Amy J Bastian, PhD, PT, Motion Analysis Lab in the Kennedy Krieger Institute
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
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer i nervesystemet
- Neoplasmer i sentralnervesystemet
- Dyskinesier
- Neoplasmer i hjernen
- Infratentorielle neoplasmer
- Ataksi
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Cerebellar ataksi
- Cerebellare neoplasmer
- Cerebellare sykdommer
- Terapeutikk
Andre studie-ID-numre
- IRB00519286
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