tRNS Treatment for ADHD Symptoms

ADHD Clinical Trial

Official title:

tRNS Treatment for ADHD Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06189703
• Other study ID #: TRNS-CLIN-003
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: Innosphere
• Contact: Rami Shacour
• Phone: +972-52-872-3640
• Email: Rami.shacour[@]inno-sphere.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, sham-controlled, double-blind clinical trial to examine the safety and effectiveness of tRNS on unmedicated pediatric patients (7-12 years) with ADHD. Subjects will undergo either tRNS or sham treatment for 10 days during a two-week period in a home-simulated environment. Each treatment session is 20 minutes, during which their attention will be maintained using a software game.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 146
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

INCLUSION CRITERIA:

1. Age between 7-12 years old at the time of enrollment

2. Estimated Full Scale IQ = 85 based on WASI-II (Two-subtests Form) NOTE: Results of an equivalent and validated IQ test that were performed in the previous 12 months from the date of enrollment are acceptable. The Investigator must ensure that no significant head injuries, particularly significant head trauma, occurred in this period from the previous test to the enrollment.

3. Score above the standard clinical cut-off score for ADHD symptoms on the ADHD DSM-5 scales

4. Meet criteria for ADHD according to DSM-5, using the "gold standard" procedure as described by the American Academy of Pediatrics, which includes a semi-structured interview of the subject and parent(s)/legal guardian(s)

5. Moderate to severe ADHD as defined as having a minimum score of 12 on either the inattention subscale or the and hyperactivity-impulsivity subscale of the baseline ADHD Rating Scale (ADHD-RS), and a Clinical Global Impression-Severity (CGI-S) score at baseline of greater than 4

6. Parent(s)/legal guardian(s) fluent in English, able to complete ADHD-RS scale and attend all study visits

7. Has not taken any medication with central nervous system effects, including prescription medications for ADHD, within 7 days of enrollment, as determined by the investigator based on the subject's medical history from the parent(s)/legal guardian(s) and, as applicable, medical and pharmacy records

EXCLUSION CRITERIA:

1. Has a history of any medical or psychiatric disorder, disease, condition, injury, symptoms or circumstance that, in the opinion of the principal investigator, may: (1) reduce the subject's ability to fulfill the study requirements as per protocol; or (2) adversely impact the integrity of the data or the validity of the study results

2. Primary DSM-5 axis-1 disorder other than ADHD, which consists of one or more of severe ODD, bipolar psychosis, major depressive disorder, severe oppositional defiant disorder that would pose adherence challenges by the investigator

3. Substance abuse, that, in the opinion of the investigator, may: (1) reduce the participant's ability to fulfill the study requirements as per protocol; or (2) adversely impact the integrity of the data or the validity of the study results

4. Impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the Investigator

5. Known hypersensitivity to Polyamide or Elastomer

6. Any suicide risk as assessed with the Columbia-Suicide Severity Rating Scale (Pediatric (=11 years) Quick Screen)

7. If female, began menstruation, based on a self- or parent(s)/legal guardian(s)-report

8. Any other condition, which would make the participant unsuitable to participate in this study as determined by the Investigator

9. Inability to provide informed consent and assent (participant and parent(s)/legal guardian(s))

Related Conditions & MeSH terms

• ADHD

Intervention

Device:
• tRNS
transcranial random noise stimulation applied to the right IFG and the left DLPFC

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Baylor College of Medicine Department of Psychiatry & Behavioral Sciences	Houston	Texas
United States	UTHealth Houston	Houston	Texas
United States	Mayo Clinic Hospital, Methodist Campus	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Innosphere

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ADHD symptom severity during treatment	Change in ADHD symptom severity, measured by total score of parent-reported ADHD-RS questionnaire from baseline to End of Treatment (Week 2) compared to sham control.	Baseline to End of Treatment (Week 2)
Primary	Incidence of adverse events	Incidence of adverse events (AEs), including serious adverse events (SAEs) related to Novostim 2 treatment	Baseline to Week 10
Secondary	Change in ADHD symptom severity post-treatment	Change in ADHD-RS from baseline to follow-up (Week 4 and Week 10) compared to sham control	Baseline to Follow-up 1 (Week 4) and to Follow-up 2 (Week 10)
Secondary	Change in ADHD-RS subscales	Change in ADHD-RS subscales (either inattention or hyperactivity-impulsivity subscales) from baseline to end of treatment and follow-up (Week 4 and Week 10) compared to sham control	Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)
Secondary	GCI-I score	CGI-I score at end of treatment and follow-up (Week 4 and Week 10) compared to sham control	Baseline to End of Treatment (Week 2), Follow-up 1 (Week 4) and Follow-up 2 (Week 10)