Anorexia NervosaNCT02535780
Transcranial Treatments in Eating Disorders
A study testing Transcranial magnetic stimulation and Transcranial direct current stimulation in people with Anorexia Nervosa and Bulimia Nervosa, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- Transcranial magnetic stimulation and Transcranial direct current stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver and Health Science Center
Aurora, Colorado, 80045
About this study
Official title: Novel Transcranial Treatments to Modulate Taste Reward and Body Perception Pathways in Eating Disorders
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.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationProcedure or surgery
TMS
Transcranial direct current stimulationProcedure or surgery
tDCS
| Study group | Role | What they receive |
|---|---|---|
| TMS Treatment Group | Experimental | 15 sessions active Transcranial magnetic stimulation (TMS) treatment Receives: Procedure: Transcranial magnetic stimulation |
| TMS Sham Group | Sham comparator | 15 sessions sham Transcranial magnetic stimulation (TMS) treatment Receives: Procedure: Transcranial magnetic stimulation |
| tDCS Treatment Group | Experimental | 15 sessions active Transcranial direct current stimulation (tDCS) treatment Receives: Procedure: Transcranial direct current stimulation |
| tDCS Sham Group | Sham comparator | 15 sessions sham Transcranial direct current stimulation (tDCS) treatment Receives: Procedure: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
taste reward brain function activation confirmed by Functional magnetic resonance imaging (fMRI)
Change in brain activation to taste reward paradigm
Measured: 3 years
Secondary outcomes (1)
Change in self-reported measures related to eating disorder thoughts and behaviors
Self Assessment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Study procedures and time not feasible due to patient schedule
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido K. Frank, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535780
- Sponsor's protocol ID
- 13-2716
- Status last verified
- Jul 2016
- First submitted
- 6 Aug 2015
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Transcranial Treatments to Modulate Taste Reward and Body Perception Pathways in Eating Disorders
- ClinicalTrials.gov ID
- NCT02535780
- Acronym / sponsor ID
- 13-2716
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study procedures and time not feasible due to patient schedule
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TMS Treatment Group | Experimental | Procedure: Transcranial magnetic stimulation15 sessions active Transcranial magnetic stimulation (TMS) treatment |
| TMS Sham Group | Sham comparator | Procedure: Transcranial magnetic stimulation15 sessions sham Transcranial magnetic stimulation (TMS) treatment |
| tDCS Treatment Group | Experimental | Procedure: Transcranial direct current stimulation15 sessions active Transcranial direct current stimulation (tDCS) treatment |
| tDCS Sham Group | Sham comparator | Procedure: Transcranial direct current stimulation15 sessions sham Transcranial direct current stimulation (tDCS) treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationTMS | Procedure or surgery | TMS Sham Group, TMS Treatment Group |
| Transcranial direct current stimulationtDCS | Procedure or surgery | tDCS Sham Group, tDCS Treatment Group |
Primary outcome
taste reward brain function activation confirmed by Functional magnetic resonance imaging (fMRI)
Time frame: 3 years
Change in brain activation to taste reward paradigm
1 secondary outcome
Change in self-reported measures related to eating disorder thoughts and behaviors
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Study procedures and time not feasible due to patient schedule). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido K. Frank, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation and Transcranial direct current stimulation in people with Anorexia Nervosa and Bulimia Nervosa, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study procedures and time not feasible due to patient schedule). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
taste reward brain function activation confirmed by Functional magnetic resonance imaging (fMRI) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.