Effects of Transcranial Direct Current Stimulation (tDCS) on Individuals With Prader-Willi Syndrome

NCT03324906 | Unknown DMC

• 1 other identifier: 58280016.1.0000.5505
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Prader-Willi Syndrome (PWS) is a multisystemic genetic disease characterized by hypotonia, mental retardation, hyperphagia, and uncontrollable hunger due to hypothalamic dysfunction, caused by dysregulation of genes located in chromosome 15q11-q13. The goal of this study is to evaluate the effects of Transcranial Direct Current Stimulation (tDCS) on hyperphagia and behavior in PWS. Forty children and adolescents (11-24 years) with clinical and cytogenetic-molecular diagnosis of Prader-Willi syndrome will be assessed before and after 10 tDCS session with: Food Craving Questionnaire (FCQ), Aberrant Behavior Checklist (ABC), Dykens hyperphagia questionnaire. Caregivers self-reported the participant's behaviors at home and, lately, they will be categorized and quantified. tDCS will be applied for 20 minutes with electrodes of 25cm2 wrapped in cotton material soaked in saline solution. The anode at the left dorsolateral prefrontal cortex (F3) and the cathode at the contralateral area (F4). Children from 11-12 years will receive a current of 1mA; above 13 years, 2mA.

Conditions

Prader-Willi Syndrome; Obesity; Depressive Disorder; Obsessive-Compulsive Disorder

Keywords

Prader-Willi Syndrome; Obesity; Depressive disorder; Obsessive-compulsive disorder; noninvasive brain stimulation

Outcome Measures

Primary Outcomes (1)

• Hyperphagia changes

  We expect changes in hyperphagic behaviors assessed by the Dykens Scale. This is a 13-item instrument that was specifically designed to measure food-related pre-occupations and problems in PWS, as well as the severity of these concerns. Items reflected parent and offspring reports of hyperphagic symptoms gleaned from our ongoing research and clinic programs for persons with PWS and their families. The severity items were based on the definition of symptom-related impairment as operationalized by the American Psychiatric Association. Items on the Dikens Scale were rated on a five-point scale (1 = not a problem to 5 = severe and/or frequent problem). The final score will be defined as the sum of all subscales. The higher is this score, the worse is the outcome.

  This outcome will be evaluate at the baseline [T1], 10 days after baseline - last stimulation session [T2] and 30 days of follow up [T3].

Secondary Outcomes (1)

• Improve depressive symptoms

  This outcome will be evaluate at the baseline [T1], 10 days after baseline - last stimulation session [T2] and 30 days of follow up [T3].

Study Arms (2)

tDCS active Prader-Willi Syndrome

ACTIVE COMPARATOR

The anode will be placed in the left side of DLPFC (F3) of the International Electrode Placement System 10-20 and cathode will be placed in the same region of the contralateral cortex, corresponding to the area F4. The stimulation current will be 2mA (for individuals aged 14-35 years) and 1mA (for individuals aged 11 to 13 years, maintaining this intensity until the end of the stimulation), will last for thirty seconds, and the ramp will exit fifteen seconds. The stimulation will last for up to 20 minutes, for a total of 10 sessions, one a day for twice a week with a weekend break.

Device: tDCS

tDCS active Obese Subjects

ACTIVE COMPARATOR

The stimulation current will be 2mA (for individuals aged 14-35 years) and 1mA (for individuals aged 11 to 13 years, maintaining this intensity until the end of the stimulation). The start ramp, when the current will be changed from zero to 2mA (two milli amps), will last for thirty seconds, and the ramp will exit fifteen seconds. The stimulation will last for up to 20 minutes.

Device: tDCS

Interventions

tDCS DEVICE

The anode will be placed in the left side of DLPFC (F3) of the International Electrode Placement System 10-20 and cathode will be placed in the same region of the contralateral cortex, corresponding to the area F4. The stimulation current will be 2mA (for individuals aged 14-35 years) and 1mA (for individuals aged 11 to 13 years, maintaining this intensity until the end of the stimulation), will last for thirty seconds, and the ramp will exit fifteen seconds. The stimulation will last for up to 20 minutes, for a total of 10 sessions, one a day for twice a week with a weekend break.

Also known as: There aren't others interventions

tDCS active Obese Subjects; tDCS active Prader-Willi Syndrome

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adolescents aged above 11 years old;
• BMI \> 30Kg/m²
• Agreement and Consent of parents and/or guardians and adolescent to participate of the study.

You may not qualify if:

• Cognitive inability to understand instructions, as assessed by the psychiatrist, due to severe cognitive impairment;
• Presence of other associated syndromes in addition to PWS;
• Inability to travel to the research site due to complications due to obesity; for convenience, as they seek specialized centers for the care of this population and associations of Prader Willi they will be referred by those responsible for participation in the program.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Caroline Azevedo

São Paulo, 04038020, Brazil

Location

Related Publications (1)

• Azevedo C, Gomes JS, Trevizol AP, Dias AM, Cordeiro Q. At-Home Transcranial Direct Current Stimulation in Prader-Willi Syndrome With Severe Intellectual Disability: A Case Study. J ECT. 2017 Sep;33(3):e29-e30. doi: 10.1097/YCT.0000000000000409. No abstract available.

  PMID: 28383347 BACKGROUND

MeSH Terms

Conditions

Prader-Willi Syndrome; Obesity; Depressive Disorder; Obsessive-Compulsive Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mood Disorders; Mental Disorders; Anxiety Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Caroline Azevedo, especialist

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Especialist

Study Record Dates

• First Submitted: October 8, 2017
• First Posted: October 30, 2017
• Study Start: May 8, 2017
• Primary Completion: September 29, 2017
• Study Completion: November 1, 2019
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

BR (1)