NCT06437002

Brief Summary

The ability to mentally recall a motor act without any overt movement is called motor imagery (MI). The movement simulation that occurs on a cognitive level can be seen as a way in which we express the mental representation of the body in action. MI tasks can be used as a proxy for the exploration of the mental representations of the body. Interestingly, MI tasks differ in the degree of action monitoring required to resolve the task. More in detail, we can allocate MI tasks along a continuum that goes from more implicit MI tasks (less action monitoring required for the resolution of the task) to more explicit MI tasks (more action monitoring required for the resolution of the task). Eating disorders such as anorexia nervosa (AN) and bulimia nervosa (BN) are both characterized by body image distortion and impairments (i.e. overestimation of the perceived body), however, on a different state of the physical body: on one hand we have a highly malnourished body, on the other hand, we might have a healthy-looking body or an overweight body. As above mentioned, MI tasks can be used as a proxy for the exploration of the mental representations of the body and people affected by AN and BN show impairment on their imagined body. This means that people affected by AN and BN might respond differently when assessed for their MI abilities. We hypothesize that people affected by AN might show greater impairment in their motor imagery abilities because of the greater discrepancy between the physical body (malnourished) and the mental body representation in comparison to people affected by BN, who usually have a health weight, even an altered body representation. Nevertheless, we might expect the alteration of body representation not strictly linked to the physical body dimensions, in the case of no difference between AN and BN. This would be of relevance for the creation of rehabilitative programs.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jun 2024May 2026

First Submitted

Initial submission to the registry

May 20, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

June 18, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

May 20, 2024

Last Update Submit

October 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mental Motor Chronometry (MMC)

    Participants will watch a video of each movement and then will be asked to practice the movements. This will be followed by the MI condition for each body district. During the MI trials, participants will be asked to imagine performing the sequence of movements for each hand and each foot, five times, as quickly and as accurately as possible with their eyes closed. The whole-body movement trials will be imagined five times, but the block of trials will be repeated twice to ensure each body district is imagined the same number of times (e.g. imagery for the left limb was repeated for the right limb). After the MI condition participants will complete the motor execution task for each body district. The order of the body district will be randomized between participants. For each participant and each body district, we will compute the average duration of the four movements for the right and the left side separately, both in the imagery and in the motor execution conditions.

    Immediately after the intervention/procedure

Study Arms (4)

anorexia nervosa restrictive/ANr

Behavioral: Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body

anorexia nervosa binge-purging/ANbp

Behavioral: Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body

bulimia nervosa/bn

Behavioral: Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body

Health control/Hc

Behavioral: Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body

Interventions

The MMC will be used as a measure of MI and it is adapted for use in hands, feet, and the whole body as well as for online experimentation. The task is comprised of two conditions, MI, and motor execution, in which respectively participants will be asked to imagine and execute a movement sequence with both hands and feet and the whole body. Hand movements: index and thumb opposition; thumb extension from the fist; middle finger crossed on the index finger; and extension of the index and the little fingers. Foot movements: foot internal rotation, foot external rotation, foot dorsiflexion, and foot plantarflexion. Whole-body movements: take a small bow, lift arms over the head and stand on the tips of the toes (stretch), extend hands forward and lower the backside (squats) and a small jump. The types of movements required to be executed by participants are simple and do not require much energy. Therefore, people affected by AN and BN should be able to perform them without problems.

Health control/Hcanorexia nervosa binge-purging/ANbpanorexia nervosa restrictive/ANrbulimia nervosa/bn

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female subjects affected by AN (restrictive and binge-purging type) and BN who will be hospitalized at the U.O. dei Disturbi del Comportamento Alimentare, San Giuseppe Hospital, Piancavallo (VCO), Italy will be selected and will be considered eligible for participation in the study.

You may qualify if:

  • Female;
  • age between 18 and 55 years old;
  • diagnosis of AN (restrictive and binge-purging type\*), as per DSM V criteria (APA, 2013);
  • BMI ≤ 17,5 Kg/m2;
  • right-handed (i.e. Edinburgh Handedness Inventory (EHI) (Veale, 2014)).
  • Restricting type: During the last 3 months, the individual has not engaged in recurrent episodes of binge eating or purging behaviour (i.e. self-induced vomiting or the misuse of laxatives, diuretics, or enemas). This subtype describes presentations in which weight loss is accomplished primarily through dieting, fasting, and/or excessive exercise.
  • Binge-eating/purging type: During the last 3 months, the individual has engaged in recurrent episodes of binge eating or purging behaviour (i.e. self-induced vomiting or the misuse of laxatives, diuretics, or enemas).

You may not qualify if:

  • presence of motor impairments, such as: motor disorders, broken limbs, inability to move, amputation of limbs, etc… because of the nature of the tasks - see the section Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body;
  • presence of neurological deficits, motor disorders, or somatosensory perception disorders (e.g. peripheral neuropathy); previous head injury;
  • schizophrenia spectrum disorders and other psychotic disorders on an acute phase;
  • pregnancy;
  • heavy use of medication because of acute symptoms.
  • People affected by BN
  • female;
  • age between 18 and 55 years old;
  • diagnosis of BN, as per DSM V criteria (APA, 2013);
  • BMI ≤ 17,5 Kg/m2 or BMI ≥ 30 Kg/m2;
  • right-handed (i.e. EHI (Veale, 2014)).
  • presence of motor impairments, such as: motor disorders, broken limbs, inability to move, amputation of limbs, etc… because of the nature of the tasks - see the section Mental Motor Chronometry (MMC) Task Hands and Feet and Whole Body;
  • presence of neurological deficits, motor disorders, or somatosensory perception disorders (e.g. peripheral neuropathy); previous head injury;
  • schizophrenia spectrum disorders and other psychotic disorders on an acute phase;
  • pregnancy;
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

istituto Auxologico italiano IRCSS

Milan, MI, 20145, Italy

RECRUITING

MeSH Terms

Conditions

Anorexia NervosaBulimia

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Federico Brusa, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 31, 2024

Study Start

June 18, 2024

Primary Completion

June 15, 2025

Study Completion (Estimated)

May 31, 2026

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations