- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03324906
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
Unknown
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
40
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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.
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)
May 8, 2017
Primary Completion (Actual)
September 29, 2017
Study Completion (Anticipated)
November 1, 2019
Study Registration Dates
First Submitted
October 8, 2017
First Submitted That Met QC Criteria
October 24, 2017
First Posted (Actual)
October 30, 2017
Study Record Updates
Last Update Posted (Actual)
November 6, 2017
Last Update Submitted That Met QC Criteria
October 31, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Mood Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Overnutrition
- Nutrition Disorders
- Genetic Diseases, Inborn
- Personality Disorders
- Anxiety Disorders
- Intellectual Disability
- Abnormalities, Multiple
- Chromosome Disorders
- Obesity
- Depression
- Depressive Disorder
- Syndrome
- Disease
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Prader-Willi Syndrome
Other Study ID 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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