NCT02535780

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

August 6, 2015

Last Update Submit

July 21, 2016

Conditions

Anorexia NervosaBulimia Nervosa

Outcome Measures

Primary Outcomes (1)

  • taste reward brain function activation confirmed by Functional magnetic resonance imaging (fMRI)

    Change in brain activation to taste reward paradigm

    3 years

Secondary Outcomes (1)

  • Change in self-reported measures related to eating disorder thoughts and behaviors

    3 years

Study Arms (4)

TMS Treatment Group

EXPERIMENTAL

15 sessions active Transcranial magnetic stimulation (TMS) treatment

Procedure: Transcranial magnetic stimulation

TMS Sham Group

SHAM COMPARATOR

15 sessions sham Transcranial magnetic stimulation (TMS) treatment

Procedure: Transcranial magnetic stimulation

tDCS Treatment Group

EXPERIMENTAL

15 sessions active Transcranial direct current stimulation (tDCS) treatment

Procedure: Transcranial direct current stimulation

tDCS Sham Group

SHAM COMPARATOR

15 sessions sham Transcranial direct current stimulation (tDCS) treatment

Procedure: Transcranial direct current stimulation

Interventions

Transcranial magnetic stimulationPROCEDURE

TMS

TMS Sham GroupTMS Treatment Group
Transcranial direct current stimulationPROCEDURE

tDCS

tDCS Sham GrouptDCS Treatment Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver and Health Science Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Anorexia NervosaBulimia Nervosa

Interventions

Transcranial Magnetic StimulationTranscranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsElectric Stimulation TherapyConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Guido K. Frank, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 31, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 25, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)