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

October 31, 2017 updated by: Caroline Azevedo, Federal University of São Paulo

Effects of Transcranial Direct Current Stimulation (tDCS) on Obsessive Compulsive Behavior and Depressive Symptoms on Individuals With Prader-Willi Syndrome

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prader-Willi syndrome (PWS) is a complex neurodevelopmental disorder that affects about 1 in 20,000 births, regardless of sex or race. PWS is characterized by two clinical phases. In the first, the cardinal symptoms are: neonatal hypotonia, feeding difficulty, lethargy, weak crying and hyporeflexia. The second, from six months, presents gradual improvement of hypotonia, weight gain and progressive development of hyperphagia and obesity. A recent trend is the use of transcranial Direct Current Stimulation (tDCS), a very simple, safe and inexpensive technique of cerebral stimulation, noninvasive and painless. It is based on the application of low intensity direct current (0-2 mA) through electrodes. tDCS has been shown to be a safe, easily tolerable method, allowing its therapeutic use in several clinical situations involving sustained cortical dysfunction such as in neurological or psychiatric disorders, including Schizophrenia, Alzheimer's Disease, Parkinson's Disease and major depression. These and other studies have been shown to be consistent with tDC's therapeutic methodology, thus favoring more accurate conclusions about the efficacy and efficiency of the method. The general objective of this research is to evaluate the effects of tDCS on the treatment Obsessive Compulsive Behavior and depressive symptoms in PWS; evaluate and compare the participants' cerebral activation pattern through electroencephalographic mapping with resting-quantitative EEG (qEEG), before and after the intervention; check if the changes (if any) last 3 months after the end of the intervention (follow up). 40 individuals will be invited to participate in this study, divided into 2 groups: 20 patients with PWS, in the age group between 11 and 35 years of age diagnosed and 20 obese individuals without the diagnosis of PWS. All will receive the same pacing protocol in terms of number of sessions and pacing time, tDCS intensity will be adjusted to 1mA in subjects aged 11 to 13 years and up to 2mA in subjects aged 14-35 years. The project will include Neuropsychological evaluation for each patient and electroencephalographic mapping with resting qEEG, before and after the intervention at the beginning of the experiment, at the end of the experiment and 30 days after (follow up).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04038020
        • Caroline Azevedo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: tDCS active Prader-Willi Syndrome
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
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.
Other Names:
  • There aren't others interventions
Active Comparator: tDCS active Obese Subjects
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
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.
Other Names:
  • There aren't others interventions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hyperphagia changes
Time Frame: This outcome will be evaluate at the baseline [T1], 10 days after baseline - last stimulation session [T2] and 30 days of follow up [T3].
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improve depressive symptoms
Time Frame: This outcome will be evaluate at the baseline [T1], 10 days after baseline - last stimulation session [T2] and 30 days of follow up [T3].
We expect to improve depressive symptoms assessed by the Beck Depression Inventory (BDI). This is a 21-item self-report inventory, which assess depressive symptoms in the last seven days. The cut-off point for this scale is defined by: <10 = no symptoms of depression; 10 - 18 = slight to moderate symptoms of depression; 19 - 29 = moderate to severe symptoms of depression; and 30 - 63 = severe symptoms of depression. The final score will be defined based on 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].

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of São Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Caroline Azevedo, especialist, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 58280016.1.0000.5505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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