Attention Deficit Hyperactivity Disorder (ADHD)MT-ADHDNCT07029425
Effectiveness of Manual Therapy in the Treatment of Attention Deficit Hyperactivity Disorder
A study testing Procedure: craniosacral therapy techniques. in people with Attention Deficit Hyperactivity Disorder (ADHD), run by JJ JIMENEZ-REJANO at 1 site in Spain.
Trial summary
The main objective is to determine whether Manual Therapy (MT), in addition to conventional treatment, is more effective in improving ADHD symptoms than the application of conventional treatment alone. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Procedure: craniosacral therapy techniques.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed ADHD diagnosis according to DSM-5 criteria.
- Children and adolescents aged 6 to 12 years.
- Availability to attend all Manual Therapy (MT) sessions.
- Informed consent signed by legal guardians.
Who cannot join
- Severe concomitant psychiatric or neurological disorders (e.g., epilepsy, severe autism spectrum disorder, schizophrenia).
- Medical conditions that contraindicate MT (e.g., fractures, severe scoliosis, connective tissue diseases).
- Recent use of or changes in ADHD medication within the past 4 weeks.
- Simultaneous participation in other interventional studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla, Sevilla, Spain 41009
Alcalá de Henares, Madrid, 28804
Paloma Felipe-Ballesteros, PT, +34672783021, paloma.felipe@edu.auh.es
Paloma Felipe-Ballesteros, PT
About this study
The main objective is to determine whether Manual Therapy (MT), in addition to conventional treatment, is more effective in improving ADHD symptoms than the application of conventional treatment alone.
Read the detailed description
Background ADHD is a disorder that affects attention, behavior control, and emotions in children. Although medication and behavioral therapy can help, not all children respond well or may experience side effects, which leads to the search for alternative options. This disorder affects the daily lives of both the child and their family, and in adulthood, it can cause emotional, social, and work-related problems. Treatment usually includes medication, cognitive-behavioral therapy, parent training, and techniques such as mindfulness. A newer option is manual therapy (MT), which uses massage and craniosacral therapy to support the nervous system and improve emotional and behavioral regulation. Although some studies have shown promising results, more research is needed to confirm its effectiveness.
Materials and Methods: A randomized clinical trial will be conducted. The minimum sample size required for statistical significance is 60 subjects, divided into two groups with 30 participants each. The primary variable will be hyperactivity and attention deficit, assessed using the Conners Parent Rating Scale and the Conners Teacher Rating Scale. The secondary variable will be mood, measured using a facial expression scale.
Objetives To determine whether the addition of manual therapy to conventional treatment is more effective in improving ADHD symptoms than conventional treatment alone.
- Being tested
- Procedure: craniosacral therapy techniques., Placebo Group
- Keywords
- Attention Deficit Hyperactivity Disorder, manual therapy, pediatrics
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: craniosacral therapy techniques.Procedure or surgery
Participants in the experimental group will receive Manual Therapy (MT) designed for this study, which will include craniosacral therapy techniques. The sessions will last 40 minutes and will be conducted twice a week for the first 4 weeks, followed by once a week for the final 4 weeks.
Placebo GroupProcedure or surgery
The placebo group will receive a dummy treatment with a duration of 40min, twice a week for the firt 4 week, follwed by once a week for the final 4 week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: craniosacral therapy techniques. | Experimental | Experimental:
Participants in the experimental group will receive Manual Therapy (MT) designed for this study, which will include craniosacral therapy techniques. The sessions will last 40 minutes and will be conducted twice a week for the first 4 weeks, followed by once a week for the final 4 weeks. Receives: Procedure: Procedure: craniosacral therapy techniques. |
| Control: placebo comparator. | Placebo comparator | Sham Comparator:
The placebo group will receive a dummy treatment with a duration of 40min, twice a week for the firt 4 week, follwed by once a week for the final 4 week. Receives: Procedure: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of ADHD (Parents Rating Scale)
Conners Parents Rating Scale. 48 items 0 = Never, 1 = Sometimes, 2 = Often, and 3 = Very Often. Scores 0-144. Scores greater than or equal to 59 = normal range, Scores 60-64 = mildly elevated symptom severity, Scores 65-69 = moderately elevated severity Scores > 70 = presence of highly elevated severity.
Measured: At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).
Symptoms of ADHD (Teacher Rating Scale)
Conners Teacher Rating Scale. 28 items. 0 = Never, 1 = Sometimes, 2 = Often, and 3 = Very Often. Scores 0-84. Scores greater than or equal to 59 = normal range, Scores 60-64 = mildly elevated symptom severity, Scores 65-69 = moderately elevated severity Scores > 70 = presence of highly elevated severity.
Measured: At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).
Secondary outcomes (1)
Mood
Facial Expression Scale. It represents expressions from sadness (scored with 1) to happiness (scored with 4).
Measured: At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JJ JIMENEZ-REJANO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JJ JIMENEZ-REJANO, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029425
- Sponsor's protocol ID
- USeville-PFB
- Acronym
- MT-ADHD
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chan SKC, Zhang D, Bogels SM, Chan CS, Lai KYC, Lo HHM, Yip BHK, Lau ENS, Gao TT, Wong SYS. Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial. BMJ Open. 2018 Nov 12;8(11):e022514. doi: 10.1136/bmjopen-2018-022514.
PubMed 30420347Accorsi A, Lucci C, Di Mattia L, Granchelli C, Barlafante G, Fini F, Pizzolorusso G, Cerritelli F, Pincherle M. Effect of osteopathic manipulative therapy in the attentive performance of children with attention-deficit/hyperactivity disorder. J Am Osteopath Assoc. 2014 May;114(5):374-81. doi: 10.7556/jaoa.2014.074.
PubMed 24778002Danckaerts M, Sonuga-Barke EJ, Banaschewski T, Buitelaar J, Dopfner M, Hollis C, Santosh P, Rothenberger A, Sergeant J, Steinhausen HC, Taylor E, Zuddas A, Coghill D. The quality of life of children with attention deficit/hyperactivity disorder: a systematic review. Eur Child Adolesc Psychiatry. 2010 Feb;19(2):83-105. doi: 10.1007/s00787-009-0046-3. Epub 2009 Jul 26.
PubMed 19633992Crouzet L, Gramond A, Suehs C, Fabbro-Peray P, Abbar M, Lopez-Castroman J. Third-generation cognitive behavioral therapy versus treatment-as-usual for attention deficit and hyperactivity disorder: a multicenter randomized controlled trial. Trials. 2022 Jan 28;23(1):83. doi: 10.1186/s13063-021-05983-2.
PubMed 35090544Bellato A, Arora I, Hollis C, Groom MJ. Is autonomic nervous system function atypical in attention deficit hyperactivity disorder (ADHD)? A systematic review of the evidence. Neurosci Biobehav Rev. 2020 Jan;108:182-206. doi: 10.1016/j.neubiorev.2019.11.001. Epub 2019 Nov 10.
PubMed 31722229Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry. 2007 Jun;164(6):942-8. doi: 10.1176/ajp.2007.164.6.942.
PubMed 17541055Robertz AC, Tornhage CJ, Nilsson S, Nyman V, Kantzer AK. Positive effects of tactile massage for adolescents with Attention Deficit/Hyperactivity Disorder (ADHD) - A small scale study. Complement Ther Clin Pract. 2024 Nov;57:101909. doi: 10.1016/j.ctcp.2024.101909. Epub 2024 Sep 25.
PubMed 39332064Musser ED, Backs RW, Schmitt CF, Ablow JC, Measelle JR, Nigg JT. Emotion regulation via the autonomic nervous system in children with attention-deficit/hyperactivity disorder (ADHD). J Abnorm Child Psychol. 2011 Aug;39(6):841-52. doi: 10.1007/s10802-011-9499-1.
PubMed 21394506Duric NS, Assmus J, Gundersen D, Duric Golos A, Elgen IB. Multimodal treatment in children and adolescents with attention-deficit/hyperactivity disorder: a 6-month follow-up. Nord J Psychiatry. 2017 Jul;71(5):386-394. doi: 10.1080/08039488.2017.1305446. Epub 2017 Mar 27.
PubMed 28345387Steinau S. Diagnostic Criteria in Attention Deficit Hyperactivity Disorder - Changes in DSM 5. Front Psychiatry. 2013 May 30;4:49. doi: 10.3389/fpsyt.2013.00049. eCollection 2013. No abstract available.
PubMed 23755024Pumprla J, Howorka K, Groves D, Chester M, Nolan J. Functional assessment of heart rate variability: physiological basis and practical applications. Int J Cardiol. 2002 Jul;84(1):1-14. doi: 10.1016/s0167-5273(02)00057-8.
PubMed 12104056Rechberger V, Biberschick M, Porthun J. Effectiveness of an osteopathic treatment on the autonomic nervous system: a systematic review of the literature. Eur J Med Res. 2019 Oct 25;24(1):36. doi: 10.1186/s40001-019-0394-5.
PubMed 31653268Mizuno Y, Cai W, Supekar K, Makita K, Takiguchi S, Tomoda A, Menon V. Methylphenidate remediates aberrant brain network dynamics in children with attention-deficit/hyperactivity disorder: A randomized controlled trial. Neuroimage. 2022 Aug 15;257:119332. doi: 10.1016/j.neuroimage.2022.119332. Epub 2022 May 28.
PubMed 35640787Haugan AJ, Sund AM, Young S, Thomsen PH, Lydersen S, Novik TS. Cognitive behavioural group therapy as addition to psychoeducation and pharmacological treatment for adolescents with ADHD symptoms and related impairments: a randomised controlled trial. BMC Psychiatry. 2022 Jun 2;22(1):375. doi: 10.1186/s12888-022-04019-6.
PubMed 35655149Cai W, Mizuno Y, Tomoda A, Menon V. Bayesian dynamical system analysis of the effects of methylphenidate in children with attention-deficit/hyperactivity disorder: a randomized trial. Neuropsychopharmacology. 2023 Oct;48(11):1690-1698. doi: 10.1038/s41386-023-01668-3. Epub 2023 Jul 25.
PubMed 37491674
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Therapy in the Treatment of Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT07029425
- Acronym / sponsor ID
- MT-ADHD / USeville-PFB
- Keywords
- Attention Deficit Hyperactivity Disorder, manual therapy, pediatrics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- JJ JIMENEZ-REJANOUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Jun 2025 (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.
The main objective is to determine whether Manual Therapy (MT), in addition to conventional treatment, is more effective in improving ADHD symptoms than the application of conventional treatment alone.
Detailed description
Background ADHD is a disorder that affects attention, behavior control, and emotions in children. Although medication and behavioral therapy can help, not all children respond well or may experience side effects, which leads to the search for alternative options. This disorder affects the daily lives of both the child and their family, and in adulthood, it can cause emotional, social, and work-related problems. Treatment usually includes medication, cognitive-behavioral therapy, parent training, and techniques such as mindfulness. A newer option is manual therapy (MT), which uses massage and craniosacral therapy to support the nervous system and improve emotional and behavioral regulation. Although some studies have shown promising results, more research is needed to confirm its effectiveness.
Materials and Methods: A randomized clinical trial will be conducted. The minimum sample size required for statistical significance is 60 subjects, divided into two groups with 30 participants each. The primary variable will be hyperactivity and attention deficit, assessed using the Conners Parent Rating Scale and the Conners Teacher Rating Scale. The secondary variable will be mood, measured using a facial expression scale.
Objetives To determine whether the addition of manual therapy to conventional treatment is more effective in improving ADHD symptoms than conventional treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: craniosacral therapy techniques. | Experimental | Procedure: Procedure: craniosacral therapy techniques.Experimental: Participants in the experimental group will receive Manual Therapy (MT) designed for this study, which will include craniosacral therapy techniques. The sessions will last 40 minutes and will be conducted twice a week for the first 4 weeks, followed by once a week for the final 4 weeks. |
| Control: placebo comparator. | Placebo comparator | Procedure: Placebo GroupSham Comparator: The placebo group will receive a dummy treatment with a duration of 40min, twice a week for the firt 4 week, follwed by once a week for the final 4 week. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Confirmed ADHD diagnosis according to DSM-5 criteria.
- Children and adolescents aged 6 to 12 years.
- Availability to attend all Manual Therapy (MT) sessions.
- Informed consent signed by legal guardians.
Key exclusion criteria (4 listed)
- Severe concomitant psychiatric or neurological disorders (e.g., epilepsy, severe autism spectrum disorder, schizophrenia).
- Medical conditions that contraindicate MT (e.g., fractures, severe scoliosis, connective tissue diseases).
- Recent use of or changes in ADHD medication within the past 4 weeks.
- Simultaneous participation in other interventional studies.
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 |
|---|---|---|
| Procedure: craniosacral therapy techniques.Participants in the experimental group will receive Manual Therapy (MT) designed for this study, which will include craniosacral therapy techniques. The sessions will last 40 minutes and will be conducted twice a week for the first 4 weeks, followed by once a week for the final 4 weeks. | Procedure or surgery | Experimental: craniosacral therapy techniques. |
| Placebo GroupThe placebo group will receive a dummy treatment with a duration of 40min, twice a week for the firt 4 week, follwed by once a week for the final 4 week. | Procedure or surgery | Control: placebo comparator. |
Primary outcome
Symptoms of ADHD (Parents Rating Scale)
Time frame: At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).
Conners Parents Rating Scale. 48 items 0 = Never, 1 = Sometimes, 2 = Often, and 3 = Very Often. Scores 0-144. Scores greater than or equal to 59 = normal range, Scores 60-64 = mildly elevated symptom severity, Scores 65-69 = moderately elevated severity Scores > 70 = presence of highly elevated severity.
Symptoms of ADHD (Teacher Rating Scale)
Time frame: At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).
Conners Teacher Rating Scale. 28 items. 0 = Never, 1 = Sometimes, 2 = Often, and 3 = Very Often. Scores 0-84. Scores greater than or equal to 59 = normal range, Scores 60-64 = mildly elevated symptom severity, Scores 65-69 = moderately elevated severity Scores > 70 = presence of highly elevated severity.
1 secondary outcome
Mood
Time frame: At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Background: PubMed 30420347Chan SKC, Zhang D, Bogels SM, Chan CS, Lai KYC, Lo HHM, Yip BHK, Lau ENS, Gao TT, Wong SYS. Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial. BMJ Open. 2018 Nov 12;8(11):e022514. doi: 10.1136/bmjopen-2018-022514.
- Background: PubMed 24778002Accorsi A, Lucci C, Di Mattia L, Granchelli C, Barlafante G, Fini F, Pizzolorusso G, Cerritelli F, Pincherle M. Effect of osteopathic manipulative therapy in the attentive performance of children with attention-deficit/hyperactivity disorder. J Am Osteopath Assoc. 2014 May;114(5):374-81. doi: 10.7556/jaoa.2014.074.
- Background: PubMed 19633992Danckaerts M, Sonuga-Barke EJ, Banaschewski T, Buitelaar J, Dopfner M, Hollis C, Santosh P, Rothenberger A, Sergeant J, Steinhausen HC, Taylor E, Zuddas A, Coghill D. The quality of life of children with attention deficit/hyperactivity disorder: a systematic review. Eur Child Adolesc Psychiatry. 2010 Feb;19(2):83-105. doi: 10.1007/s00787-009-0046-3. Epub 2009 Jul 26.
- Background: PubMed 35090544Crouzet L, Gramond A, Suehs C, Fabbro-Peray P, Abbar M, Lopez-Castroman J. Third-generation cognitive behavioral therapy versus treatment-as-usual for attention deficit and hyperactivity disorder: a multicenter randomized controlled trial. Trials. 2022 Jan 28;23(1):83. doi: 10.1186/s13063-021-05983-2.
- Background: PubMed 31722229Bellato A, Arora I, Hollis C, Groom MJ. Is autonomic nervous system function atypical in attention deficit hyperactivity disorder (ADHD)? A systematic review of the evidence. Neurosci Biobehav Rev. 2020 Jan;108:182-206. doi: 10.1016/j.neubiorev.2019.11.001. Epub 2019 Nov 10.
- Background: PubMed 17541055Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry. 2007 Jun;164(6):942-8. doi: 10.1176/ajp.2007.164.6.942.
- Background: PubMed 39332064Robertz AC, Tornhage CJ, Nilsson S, Nyman V, Kantzer AK. Positive effects of tactile massage for adolescents with Attention Deficit/Hyperactivity Disorder (ADHD) - A small scale study. Complement Ther Clin Pract. 2024 Nov;57:101909. doi: 10.1016/j.ctcp.2024.101909. Epub 2024 Sep 25.
- Background: PubMed 21394506Musser ED, Backs RW, Schmitt CF, Ablow JC, Measelle JR, Nigg JT. Emotion regulation via the autonomic nervous system in children with attention-deficit/hyperactivity disorder (ADHD). J Abnorm Child Psychol. 2011 Aug;39(6):841-52. doi: 10.1007/s10802-011-9499-1.
- Background: PubMed 28345387Duric NS, Assmus J, Gundersen D, Duric Golos A, Elgen IB. Multimodal treatment in children and adolescents with attention-deficit/hyperactivity disorder: a 6-month follow-up. Nord J Psychiatry. 2017 Jul;71(5):386-394. doi: 10.1080/08039488.2017.1305446. Epub 2017 Mar 27.
- Background: PubMed 23755024Steinau S. Diagnostic Criteria in Attention Deficit Hyperactivity Disorder - Changes in DSM 5. Front Psychiatry. 2013 May 30;4:49. doi: 10.3389/fpsyt.2013.00049. eCollection 2013. No abstract available.
- Background: PubMed 12104056Pumprla J, Howorka K, Groves D, Chester M, Nolan J. Functional assessment of heart rate variability: physiological basis and practical applications. Int J Cardiol. 2002 Jul;84(1):1-14. doi: 10.1016/s0167-5273(02)00057-8.
- Background: PubMed 31653268Rechberger V, Biberschick M, Porthun J. Effectiveness of an osteopathic treatment on the autonomic nervous system: a systematic review of the literature. Eur J Med Res. 2019 Oct 25;24(1):36. doi: 10.1186/s40001-019-0394-5.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: craniosacral therapy techniques. in people with Attention Deficit Hyperactivity Disorder (ADHD), run by JJ JIMENEZ-REJANO at 1 site in Spain.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Jun 2025. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paloma Felipe-Ballesteros, PT (+34 672783021, paloma.felipe@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of ADHD (Parents Rating Scale) (time frame: At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).). The study lists 2 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 NCT07029425, which also lists 20 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 27 Jun 2025.