CravingNCT05046145
Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Oxidative Stress.
A study testing speech therapy for chewing + real tDCS in people with Craving and Mastication Disorder, run by Universidade Federal do Piauí at 1 site in Brazil.
Trial summary
From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Craving, Mastication Disorder, Memory Disorders
- What is being tested?
- speech therapy for chewing + real tDCS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Jul 2021to 31 Oct 2022
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being a health professional at the HU-UFPI (higher and technical levels);
- both sexes;
- Age between 20 and 59 years old.
Who cannot join
- Participants with communication disabilities (outbound or inbound);
- Type 1 and 2 diabetes
- low Body Mass Index (BMI; below 18.5),
- intracranial metal clip and/or prostheses;
- Abrupt change in weight (> 5 kg) in the last six months;
- the use will be excluded recreational use of psychoactive drugs,
Show all 14Show fewer
- Being a smoker or using nicotine (tablet / absorbent),
- Having had significant recent trauma or traumatic brain injury,
- Present history of epilepsy,
- to be pregnant or under suspicion
- Missing teeth;
- Medical diagnosis of eating disorder or any psychiatric disorder,
- Having or having had cancer,
- Diagnosis of heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Biochemical Markers of Inflammation and Oxidative Stress
From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information. Provoking changes in neuroplasticity and cortical excitability contribute to the regulation of neural activity. Both could be modified by applying direct electrical current to the sensorimotor cortex, with polarity/current-dependent results, and their effect would last for hours after the end of stimulation. Transcranial Direct Current Stimulation (tDCS), translated into Portuguese as Estimulação Transcraniana por Corrente Contínua (ETCC) is a neuromodulating tool in which a low-intensity electrical current is applied to the scalp to modulate neuronal activity.
- Conditions
- Craving, Mastication Disorder, Memory Disorders, Executive Dysfunction, Transcranial Direct Current Stimulation, Inflammation
- Being tested
- speech therapy for chewing + real tDCS
- Keywords
- Craving, Executive Dysfunction, Oxidative Stress, Transcranial Direct Current Stimulation
- Medical subject headings
- Memory Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech therapy for chewing + real tDCSBehavioural
Also called speech therapy for chewing + sham tDCS
participants will be instructed to chew their food correctly during the tDCS session, but the participant does not know if the tdcs is real or sham.
| Study group | Role | What they receive |
|---|---|---|
| tDCS + speech therapy+ sham | Experimental | Participants will receive real tDCS and tDCS sham for 5 sessions during each treatment period. The interstice period of the total intervention will be 25 days, with 15 days of wash out between the two interventions. The probabilistic, simple randomized sample will consist of participants with food cravings randomized into two groups, according to the presence or absence of changes in eating behavior and within each group there will be subdivision to receive or not neuromodulation, according to the flowchart Receives: Behavioral: speech therapy for chewing + real tDCS |
| sham + tDCS + speech therapy | Experimental | Participants will receive real tDCS and tDCS sham for 5 sessions during each treatment period. The interstice period of the total intervention will be 25 days, with 15 days of wash out between the two interventions. The probabilistic, simple randomized sample will consist of participants with food cravings randomized into two groups, according to the presence or absence of changes in eating behavior and within each group there will be subdivision to receive or not neuromodulation, according to the flowchart Receives: Behavioral: speech therapy for chewing + real tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in desire to consume food.
Questionnaires of Intense Food Desires - Trait (QDIC-T) validated for Brazilian Portuguese. The higher the score, the greater the amount of food craving presented.The QDIC-T scale is done on a 6-point scale with scores ranging from 39 to 214 points.
Measured: pre-intervention.
change in desire to consume food.
Questionnaires of Intense Food Desires - Trait (QDIC-T) validated for Brazilian Portuguese. The higher the score, the greater the amount of food craving presented. The QDIC-T scale is done on a 6-point scale with scores ranging from 39 to 214 points.
Measured: post-intervention (immediately after the end of study participation).
change in the executive brain functions - working memory
Trial Making Test (A and B). Assessments with single measurements (measurement of time, in seconds, to perform the test).
the measurement unit for evaluating the outcome of these tests will be the amount of errors presented and the execution time (in seconds). The shorter the time and fewer errors, the better the result.
Measured: pre-intervention.
change in the executive brain functions - cognitive flexibility
Stroop Tests. Assessments with single measurements (measurement of time, in seconds, to perform the test).
the measurement unit for evaluating the outcome of these tests will be the amount of errors presented and the execution time (in seconds). The shorter the time and fewer errors, the better the result.
Measured: post-intervention (immediately after the end of study participation).
Secondary outcomes (6)
change in the final value of inflammation scores
inflammation markers (PCR in serum). The biochemical dosage of all elements will be in mg/L, higher values will represent a higher concentration, that is, a greater degree of inflammatory processes.
Measured: pre-intervention.
change in the final value of inflammation scores
inflammation markers (PCR in serum). The biochemical dosage of all elements will be in mg/L, higher values will represent a higher concentration, that is, a greater degree of inflammatory processes.
Measured: post-intervention (immediately after the end of study participation).
change in the final value of antioxidant activity
antioxidant activity (Catalase in erythrocytes). The biochemical dosage of all elements will be in mg/L, higher values will represent a higher concentration, that is, a greater degree of inflammatory processes.
Measured: pre-intervention.
change in the final value of antioxidant activity
antioxidant activity (Catalase in erythrocytes). The biochemical dosage of all elements will be in mg/L, higher values will represent a higher concentration, that is, a greater degree of inflammatory processes.
Measured: post-intervention (immediately after the end of study participation).
change in desire to consume food.
Questionnaires of Intense Food Desires - State (QDIC-E); validated for Brazilian Portuguese. QDIC-E is made up of a five-point scale, ranging from 15 to 75 points. The higher the score, the greater the amount of food craving presented.
Measured: pre-intervention.
change in desire to consume food.
Questionnaires of Intense Food Desires - State (QDIC-E); validated for Brazilian.Portuguese. The higher the score, the greater the amount of food craving presented. QDIC-E is made up of a five-point scale, ranging from 15 to 75 points.
Measured: post-intervention (immediately after the end of study participation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start13 Jul 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CravingStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a randomized, double-blind, parallel clinical trial. Participants will receive real tDCS or tDCS sham for 10 sessions during the treatment period. The interstice period of the total intervention will be 15 days (2 subsequent weeks, 10 working days, to apply the intervention). The probabilistic, simple randomized sample will consist of participants with randomized food cravings into two groups, there will be subdivision to receive or not neuromodulation, according to the flowchart.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Piauí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Maria da Silva Lira Batista, Federal University of Piaui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046145
- Sponsor's protocol ID
- tDCSONCRAVINGFOOD
- Status last verified
- Oct 2022
- First submitted
- 13 Aug 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THERE IS PREDICTION THAT THERE WILL BE UNDERLYING RESEARCH BASED ON THE RESULTS FOUND.
Publications
Ljubisavljevic M, Maxood K, Bjekic J, Oommen J, Nagelkerke N. Long-Term Effects of Repeated Prefrontal Cortex Transcranial Direct Current Stimulation (tDCS) on Food Craving in Normal and Overweight Young Adults. Brain Stimul. 2016 Nov-Dec;9(6):826-833. doi: 10.1016/j.brs.2016.07.002. Epub 2016 Jul 15.
PubMed 27498606Martin AA, Davidson TL, McCrory MA. Deficits in episodic memory are related to uncontrolled eating in a sample of healthy adults. Appetite. 2018 May 1;124:33-42. doi: 10.1016/j.appet.2017.05.011. Epub 2017 May 4.
PubMed 28479407Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
PubMed 31901449Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
PubMed 27866120Kane MJ, Engle RW. Working-memory capacity and the control of attention: the contributions of goal neglect, response competition, and task set to Stroop interference. J Exp Psychol Gen. 2003 Mar;132(1):47-70. doi: 10.1037/0096-3445.132.1.47.
PubMed 12656297Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
PubMed 27372845Santos Ferreira I, Teixeira Costa B, Lima Ramos C, Lucena P, Thibaut A, Fregni F. Searching for the optimal tDCS target for motor rehabilitation. J Neuroeng Rehabil. 2019 Jul 17;16(1):90. doi: 10.1186/s12984-019-0561-5.
PubMed 31315679Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
PubMed 23020641Diamond A. Executive functions. Handb Clin Neurol. 2020;173:225-240. doi: 10.1016/B978-0-444-64150-2.00020-4.
PubMed 32958176
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Biochemical Markers of Inflammation and Oxidative Stress
- ClinicalTrials.gov ID
- NCT05046145
- Acronym / sponsor ID
- tDCSONCRAVINGFOOD
- Conditions
- Craving, Mastication Disorder, Memory Disorders, Executive Dysfunction, Transcranial Direct Current Stimulation, Inflammation
- Keywords
- Craving, Executive Dysfunction, Oxidative Stress, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidade Federal do PiauíUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 16 Sep 2021 (actual)
- 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.
From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information. Provoking changes in neuroplasticity and cortical excitability contribute to the regulation of neural activity. Both could be modified by applying direct electrical current to the sensorimotor cortex, with polarity/current-dependent results, and their effect would last for hours after the end of stimulation. Transcranial Direct Current Stimulation (tDCS), translated into Portuguese as Estimulação Transcraniana por Corrente Contínua (ETCC) is a neuromodulating tool in which a low-intensity electrical current is applied to the scalp to modulate neuronal activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be a randomized, double-blind, parallel clinical trial. Participants will receive real tDCS or tDCS sham for 10 sessions during the treatment period. The interstice period of the total intervention will be 15 days (2 subsequent weeks, 10 working days, to apply the intervention). The probabilistic, simple randomized sample will consist of participants with randomized food cravings into two groups, there will be subdivision to receive or not neuromodulation, according to the flowchart.
| Arm | Type | Receives |
|---|---|---|
| tDCS + speech therapy+ sham | Experimental | Behavioral: speech therapy for chewing + real tDCSParticipants will receive real tDCS and tDCS sham for 5 sessions during each treatment period. The interstice period of the total intervention will be 25 days, with 15 days of wash out between the two interventions. The probabilistic, simple randomized sample will consist of participants with food cravings randomized into two groups, according to the presence or absence of changes in eating behavior and within each group there will be subdivision to receive or not neuromodulation, according to the flowchart |
| sham + tDCS + speech therapy | Experimental | Behavioral: speech therapy for chewing + real tDCSParticipants will receive real tDCS and tDCS sham for 5 sessions during each treatment period. The interstice period of the total intervention will be 25 days, with 15 days of wash out between the two interventions. The probabilistic, simple randomized sample will consist of participants with food cravings randomized into two groups, according to the presence or absence of changes in eating behavior and within each group there will be subdivision to receive or not neuromodulation, according to the flowchart |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being a health professional at the HU-UFPI (higher and technical levels);
- both sexes;
- Age between 20 and 59 years old.
Key exclusion criteria (14 listed)
- Participants with communication disabilities (outbound or inbound);
- Type 1 and 2 diabetes
- low Body Mass Index (BMI; below 18.5),
- intracranial metal clip and/or prostheses;
- Abrupt change in weight (> 5 kg) in the last six months;
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 |
|---|---|---|
| speech therapy for chewing + real tDCSAlso: speech therapy for chewing + sham tDCSparticipants will be instructed to chew their food correctly during the tDCS session, but the participant does not know if the tdcs is real or sham. | Behavioural | sham + tDCS + speech therapy, tDCS + speech therapy+ sham |
Primary outcome
change in desire to consume food.
Time frame: pre-intervention.
Questionnaires of Intense Food Desires - Trait (QDIC-T) validated for Brazilian Portuguese. The higher the score, the greater the amount of food craving presented.The QDIC-T scale is done on a 6-point scale with scores ranging from 39 to 214 points.
change in desire to consume food.
Time frame: post-intervention (immediately after the end of study participation).
Questionnaires of Intense Food Desires - Trait (QDIC-T) validated for Brazilian Portuguese. The higher the score, the greater the amount of food craving presented. The QDIC-T scale is done on a 6-point scale with scores ranging from 39 to 214 points.
change in the executive brain functions - working memory
Time frame: pre-intervention.
Trial Making Test (A and B). Assessments with single measurements (measurement of time, in seconds, to perform the test). the measurement unit for evaluating the outcome of these tests will be the amount of errors presented and the execution time (in seconds). The shorter the time and fewer errors, the better the result.
change in the executive brain functions - cognitive flexibility
Time frame: post-intervention (immediately after the end of study participation).
Stroop Tests. Assessments with single measurements (measurement of time, in seconds, to perform the test). the measurement unit for evaluating the outcome of these tests will be the amount of errors presented and the execution time (in seconds). The shorter the time and fewer errors, the better the result.
6 secondary outcomes
change in the final value of inflammation scores
Time frame: pre-intervention.
change in the final value of inflammation scores
Time frame: post-intervention (immediately after the end of study participation).
change in the final value of antioxidant activity
Time frame: pre-intervention.
change in the final value of antioxidant activity
Time frame: post-intervention (immediately after the end of study participation).
change in desire to consume food.
Time frame: pre-intervention.
change in desire to consume food.
Time frame: post-intervention (immediately after the end of study participation).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 27498606Ljubisavljevic M, Maxood K, Bjekic J, Oommen J, Nagelkerke N. Long-Term Effects of Repeated Prefrontal Cortex Transcranial Direct Current Stimulation (tDCS) on Food Craving in Normal and Overweight Young Adults. Brain Stimul. 2016 Nov-Dec;9(6):826-833. doi: 10.1016/j.brs.2016.07.002. Epub 2016 Jul 15.
- Background: PubMed 28479407Martin AA, Davidson TL, McCrory MA. Deficits in episodic memory are related to uncontrolled eating in a sample of healthy adults. Appetite. 2018 May 1;124:33-42. doi: 10.1016/j.appet.2017.05.011. Epub 2017 May 4.
- Background: PubMed 31901449Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- Background: PubMed 27866120Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
- Background: PubMed 12656297Kane MJ, Engle RW. Working-memory capacity and the control of attention: the contributions of goal neglect, response competition, and task set to Stroop interference. J Exp Psychol Gen. 2003 Mar;132(1):47-70. doi: 10.1037/0096-3445.132.1.47.
- Background: PubMed 27372845Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
- Background: PubMed 31315679Santos Ferreira I, Teixeira Costa B, Lima Ramos C, Lucena P, Thibaut A, Fregni F. Searching for the optimal tDCS target for motor rehabilitation. J Neuroeng Rehabil. 2019 Jul 17;16(1):90. doi: 10.1186/s12984-019-0561-5.
- Background: PubMed 23020641Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
- Background: PubMed 32958176Diamond A. Executive functions. Handb Clin Neurol. 2020;173:225-240. doi: 10.1016/B978-0-444-64150-2.00020-4.
- Ljubisavljevic M, Maxood K, Bjekic J, Oommen J, Nagelkerke N.Link provided by the sponsor.
- Martin AA, Davidson TL, McCrory MALink provided by the sponsor.
- Individual participant dataSharing planned: No. THERE IS PREDICTION THAT THERE WILL BE UNDERLYING RESEARCH BASED ON THE RESULTS FOUND.
Related trials for Craving
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Active, not recruitingPhase 3
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Misuse, Opioid
RecruitingPhase 1
Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes
Alcohol Use Disorder (AUD), Obesity (BMI Equal to or >30)
RecruitingPhase 2/3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification
Not yet recruiting
Closed-loop TMS for the Core Clinical Features of Methamphetamine Use Disorder
Methamphetamine Use Disorder, Substance Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing speech therapy for chewing + real tDCS in people with Craving and Mastication Disorder, run by Universidade Federal do Piauí at 1 site in Brazil.
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 2 Nov 2022. 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 Brazil. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in desire to consume food. (time frame: pre-intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046145, which also lists 9 linked publications.
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 2 Nov 2022.