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Trial record 31 of 533 for:    Taste Disorders AND taste

Transcranial Treatments in Eating Disorders

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ClinicalTrials.gov Identifier: NCT02535780
Recruitment Status : Terminated (Study procedures and time not feasible due to patient schedule)
First Posted : August 31, 2015
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The primary aim of this study is to study how Repetitive Transcranial Magnetic Stimulation (rTMS) tailored to specific anorexia nervosa (AN) or bulimia nervosa (BN) brain activation alterations will promote recovery and to study how inhibitory tDCS (Transcranial Direct Current Stimulation) will reduce symptoms of body image distortion in a second sample of AN and BN groups.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Bulimia Nervosa Procedure: Transcranial magnetic stimulation Procedure: Transcranial direct current stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Novel Transcranial Treatments to Modulate Taste Reward and Body Perception Pathways in Eating Disorders
Study Start Date : August 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: TMS Treatment Group
15 sessions active Transcranial magnetic stimulation (TMS) treatment
Procedure: Transcranial magnetic stimulation
TMS

Sham Comparator: TMS Sham Group
15 sessions sham Transcranial magnetic stimulation (TMS) treatment
Procedure: Transcranial magnetic stimulation
TMS

Experimental: tDCS Treatment Group
15 sessions active Transcranial direct current stimulation (tDCS) treatment
Procedure: Transcranial direct current stimulation
tDCS

Sham Comparator: tDCS Sham Group
15 sessions sham Transcranial direct current stimulation (tDCS) treatment
Procedure: Transcranial direct current stimulation
tDCS




Primary Outcome Measures :
  1. taste reward brain function activation confirmed by Functional magnetic resonance imaging (fMRI) [ Time Frame: 3 years ]
    Change in brain activation to taste reward paradigm


Secondary Outcome Measures :
  1. Change in self-reported measures related to eating disorder thoughts and behaviors [ Time Frame: 3 years ]
    Self Assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anorexia Nervosa subjects:
  • Meets DSM-5 criteria for anorexia nervosa (AN) either binge-eating/purging type or restricting-type:
  • Intense fear of gaining weight or becoming fat, even though underweight.
  • The ability to undergo an MRI, fMRI or other similar procedure requiring spending time in an enclosed space
  • Bulimia Nervosa subjects:
  • Meet DSM-5 criteria for bulimia nervosa (BN):
  • Self-induced vomiting; misuse of laxatives, diuretics, enemas, medication, fasting, excessive exercise.

Exclusion Criteria:

  • Electrolyte, blood count or kidney or liver function abnormalities.
  • No symptoms of alcohol or other substance abuse or dependence in the past 3 months,
  • No previous or current organic brain syndromes, dementia, psychotic disorders, somatization disorders, or conversion disorder, head trauma, indication of mental retardation or pervasive developmental disorder.
  • No antipsychotics, tricyclic antidepressants or Wellbutrin or other medication that may lower the seizure threshold.
  • Claustrophobia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02535780


Locations
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United States, Colorado
University of Colorado Denver and Health Science Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Guido K. Frank, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02535780     History of Changes
Other Study ID Numbers: 13-2716
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Feeding and Eating Disorders
Anorexia
Anorexia Nervosa
Bulimia
Bulimia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Hyperphagia