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Non-invasive Brain Modulation for Weight Maintenance

27. oktober 2016 opdateret af: Takara Stanley, M.D., Massachusetts General Hospital

Neurobehavioral Contribution to Weight Loss Maintenance: an Interdisciplinary Experimental Study With Noninvasive Brain Modulation

This is a study of overweight men and women. Everybody will receive a very low calorie diet to eat in place of meals for 10 weeks. During the last two weeks of the diet, half of the patients will receive an intervention to activate parts of their brain that can help them eat less. The other half of the patient will receive a placebo or sham intervention. The intervention will involve a small electric current given every day for 10 days. Everybody will be monitored for 16 more weeks (total of 26 weeks) while on a weight maintenance diet to see if the intervention helps people keep the weight off.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital

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

20 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Men and women age 20-55 years old
  2. BMI 30-50 kg/m2
  3. Willing to undergo 10 week supervised VLCD

Exclusion Criteria:

  1. Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery
  2. Subjects who have a known history of diabetes, fasting blood sugar >125 mg/dl or using any anti-diabetic drugs
  3. Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening
  4. Hemoglobin <10 g/dL, Creatinine >1.5 mg/dL
  5. QT interval >440 ms on EKG
  6. Subjects with unstable psychiatric conditions as assessed by a psychologist
  7. Allergy or intolerance to components of the mixed meal challenge
  8. Additional contraindications to receive transcranial direct current stimulation (tDCS):

    1. Personal or family history of seizures, epilepsy or other unexplained loss of consciousness.
    2. Current or past history of skin disease or damaged skin on the scalp at the site of stimulation (i.e. eczema, skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.).
    3. Prior neurosurgical procedure or radiation treatment to the brain.
    4. Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis
    5. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, ventriculoperitoneal shunt or any metallic implant on the head.

    (Note: Intake of centrally acting medications will be allowed, as there is no evidence that any medication can increase the risk of adverse effects during tDCS.)

  9. Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit
  10. Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Brain modulation
10 sessions of brain modulation with Eldith/Neuroconn transcranial Direct Current Stimulation device
Brain modulation using Eldith/Neuroconn transcranial Direct Current Stimulation device
Placebo komparator: Placebo (sham modulation)
10 placebo sessions where no brain modulation takes place

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in weight from week 11 to 26
Tidsramme: Week 11 to 26
Patients will be placed on a very low calorie diet from baseline to week 11. The primary end point is the maintenance of weight loss from week 11 to week 26 after the very low calorie diet is stopped.
Week 11 to 26

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in appetite hormones on mixed meal challenge test
Tidsramme: Week 0 to 8, 11 and 26
Appetite hormones such as ghrelin change in response to nutrition. Dieting increases ghrelin and decreases other appetite hormones. We will assess if the brain modulation intervention will prevent the dieting induced increase in ghrelin and changes in other appetite hormones.
Week 0 to 8, 11 and 26
Change in appetite
Tidsramme: Week 0 to 8, 11, 18 and 26
Degree of hunger (or satiety) can be assessed by use of visual analog scale and monitoring food intake diaries and questionnaires. We will assess if the brain modulation intervention can prevent the diet induced increases in appetite using the visual analog scale, food diary and questionnaires.
Week 0 to 8, 11, 18 and 26
Change in body composition
Tidsramme: Week 0 to 8 and 26
Weight loss can affect both fat mass and muscle (lean) mass. We will assess if the weight loss by low-calorie diet and weight maintenane facilitated by brain modulation will preferentially affect fat mass or lean mass by use of dual energy X-ray absorptiometry.
Week 0 to 8 and 26
Change in metabolic parameters
Tidsramme: Week 0 to 8, 11, 18, 26
Weight loss and successful weight loss maintenance can improve insulin resistance (risk for diabetes mellitus) and cholesterol profile. We will assess the changes in risk for diabetes and cholesterol from the low-calorie diet and brai modulation mediated weight maintenance.
Week 0 to 8, 11, 18, 26

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Takara Stanley, MD, Massachusetts General Hospital
  • Ledende efterforsker: Miguel Alonso-Alonso, MD, Beth Israel Deaconess Medical Center
  • Ledende efterforsker: Winfield S. Butsch, MD, Massachusetts General Hospital

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

1. maj 2013

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

8. februar 2013

Først indsendt, der opfyldte QC-kriterier

14. februar 2013

Først opslået (Skøn)

18. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2013-P-000191

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Brain modulation

3
Abonner