- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01793766
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
Intervention / Behandling
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
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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:
- Men and women age 20-55 years old
- BMI 30-50 kg/m2
- Willing to undergo 10 week supervised VLCD
Exclusion Criteria:
- Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery
- Subjects who have a known history of diabetes, fasting blood sugar >125 mg/dl or using any anti-diabetic drugs
- Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening
- Hemoglobin <10 g/dL, Creatinine >1.5 mg/dL
- QT interval >440 ms on EKG
- Subjects with unstable psychiatric conditions as assessed by a psychologist
- Allergy or intolerance to components of the mixed meal challenge
Additional contraindications to receive transcranial direct current stimulation (tDCS):
- Personal or family history of seizures, epilepsy or other unexplained loss of consciousness.
- 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.).
- Prior neurosurgical procedure or radiation treatment to the brain.
- Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis
- 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.)
- 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
- 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.
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Week 0 to 8, 11, 18 and 26
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Change in body composition
Tidsramme: Week 0 to 8 and 26
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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.
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Week 0 to 8 and 26
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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.
Sponsor
Samarbejdspartnere
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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