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Exercise and Brain Stimulation for Post-stroke Depression

3. marts 2020 opdateret af: Chris Gregory, Medical University of South Carolina

Treating Depression and Enhancing Locomotor Recovery Post-stroke

This project will assess the effects of aerobic exercise training (AET), repetitive transcranial magnetic stimulation (rTMS) or their combination on depressive severity as well as locomotor function in persons with post-stroke depression (PSD). Both AET and rTMS are established stand-alone treatments for non-stroke related depression, though neither has been adequately studied post-stroke. Furthermore, substantive research indicates that AET improves post-stroke locomotor function, thus offering a novel approach for treating PSD as well as an established vehicle to study the effects of PSD on response to rehabilitation.

The purpose of this project is to determine the impact of AET, rTMS and their combination (AET+rTMS) treatments on post-stroke depressive symptoms and locomotor function so as to guide the development of a future clinical trial. A total of 40 depressed post-stroke subjects will be randomly assigned to one of four groups 1) AET; 2) rTMS; 3) combined AET and rTMS (AET+rTMS) or 4) control (sham rTMS) group (n=10 per condition; equally distributed with mild and moderate MDD). Further, an additional 10 non-depressed post-stroke subjects will complete 8 weeks of AET so as to allow us to determine the effects of PSD on response to training (Aim 2). Training (AET, rTMS and AET+rTMS) will take place over an 8-week period, three times per week on non-consecutive days. Measures of depression (HRSD17) as well as self-selected walking speed (SSWS) will be performed prior to the initial treatment session of each week as well as 8 weeks following cessation of treatment. Additional measures of locomotor function (walking endurance and amount of daily community stepping) will be assessed prior to training (pre), following 4 weeks of training (mid), upon completion of 8 weeks of training (post) as well as 8 weeks following cessation of training (follow-up), allowing determination of the efficacy (and persistence) of training on these outcomes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 1) age 50-70
  • 2) stroke within the past 6 to 60 months,
  • 3) major depressive disorder (PHQ-9 > 10) and diagnosed using the Structured Clinical Interview for Depression (SCID) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV),
  • 4) residual paresis in the lower extremity (Fugl-Meyer LE motor score <34),
  • 5) ability to walk without assistance and without an AFO on the treadmill ≥ 30 seconds at speeds ranging from 0.2-0.8 m/s,
  • 6) no antidepressant medications or clinically able to discontinue medications,
  • 7) HRSD question #9 regarding suicide <2,
  • 8) provision of informed consent. In addition, all subjects who meet criteria for the training portion must complete an exercise tolerance test and be cleared for participation by the study cardiologist.

Exclusion Criteria:

  1. Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking;
  2. history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's;
  3. History of oxygen dependence;
  4. Preexisting neurological disorders, dementia or previous stroke;
  5. History of major head trauma;
  6. Legal blindness or severe visual impairment;
  7. history of psychosis or other Axis I disorder that is primary;
  8. Life expectancy <1 yr.;
  9. Severe arthritis or other problems that limit passive range of motion;
  10. History of DVT or pulmonary embolism within 6 months;
  11. Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
  12. Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest;
  13. attempt of suicide in the last 2 years or at suicidal risk assessed by SCID interview;
  14. Previous or current enrollment in a clinical trial to enhance motor recovery; 15) currently exercising ≥ 2 times per week (≥20 minutes);

16) Presence of non-MR compatible implants, pregnancy or severe claustrophobia.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Aerobic Exercise
Treadmill aerobic exercise
Adfærdsmæssigt: Aerobic exercise
treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
Eksperimentel: rTMS
repetitive transcranial magnetic stimulation
Andet: Repetitive transcranial magnetic stimulation
Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
Andre navne:
  • rTMS
Eksperimentel: AET+rTMS
Combined aerobic exercise and rTMS
Adfærdsmæssigt: Aerobic exercise
treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
Andet: Repetitive transcranial magnetic stimulation
Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
Andre navne:
  • rTMS
Sham-komparator: Sham
Sham rTMS
Andet: Repetitive transcranial magnetic stimulation
Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
Andre navne:
  • rTMS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Hamilton Rating Scale for Depression
Tidsramme: weekly throughout the 8 week intervention as well as at the 8 week follow-up visit
Rating of depressive symptom severity
weekly throughout the 8 week intervention as well as at the 8 week follow-up visit

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline in Self-selected walking speed
Tidsramme: weekly throughout the 8 week intervention as well as at the 8 week follow-up visit
weekly throughout the 8 week intervention as well as at the 8 week follow-up visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University of South Carolina

Efterforskere

  • Ledende efterforsker: Chris M Gregory, PhD, Medical University of South Carolina

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2016

Primær færdiggørelse (Faktiske)

31. december 2019

Studieafslutning (Faktiske)

31. december 2019

Datoer for studieregistrering

Først indsendt

8. februar 2017

Først indsendt, der opfyldte QC-kriterier

14. februar 2017

Først opslået (Faktiske)

17. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. marts 2020

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • COBRE: EXD

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Betingelser

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