← Back to Search

Neuromodulation

Neuromodulation for Concussion (CI-tDCS Trial)

N/A
Recruiting
Led By Ghazala Saleem, EdD
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2-5 (post initial behavioral testing), day 26- 32 (final post-anodal transcranial direct current stimulation (tdcs), day 60 -66 (final post-sham tdcs), and day 94 - 96 (post 30-days follow up behavioral testing visit).
Awards & highlights

CI-tDCS Trial Summary

This trial is testing a brain stimulation method to help children with mTBI recover motor and cognitive skills, and restore communication among affected brain areas.

Who is the study for?
This trial is for children aged 10-15 who have had a mild traumatic brain injury (mTBI) or concussion in the past year and are experiencing ongoing symptoms like trouble with motor skills. They must be at least 6 weeks post-injury, speak English fluently, and have no prior history of concussions.Check my eligibility
What is being tested?
The study is exploring the use of tDCS (transcranial direct current stimulation), a non-invasive brain stimulation technique, to improve motor and cognitive functions in youths with mTBI. It also aims to assess new ways to measure brain communication changes during recovery.See study design
What are the potential side effects?
tDCS may cause minor side effects such as tingling, itching or stinging sensation on the scalp where electrodes are placed; fatigue; headache; nausea; or discomfort during treatment.

CI-tDCS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2-5 (post initial behavioral testing), day 26- 32 (final post-anodal transcranial direct current stimulation (tdcs), day 60 -66 (final post-sham tdcs), and day 94 - 96 (post 30-days follow up behavioral testing visit).
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2-5 (post initial behavioral testing), day 26- 32 (final post-anodal transcranial direct current stimulation (tdcs), day 60 -66 (final post-sham tdcs), and day 94 - 96 (post 30-days follow up behavioral testing visit). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Motor Control Test Measurements (Posturography)
Changes in resting-state functional magnetic resonance imaging outcome
Changes in the Dual-Task Screen
+2 more
Secondary outcome measures
Changes in GAD-7
Changes in PHQ-8
Changes in WASI-II

CI-tDCS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: tDCS in Youth with mild traumatic brain injuryExperimental Treatment1 Intervention
Behavioral as well as neuroimaging measurements will be administered at the final post-anodal transcranial direct current stimulation (tDCS), final post-sham tDCS, and at 30-day follow-up visits. tDCS will be administered after the initial behavioral and neuroimaging testing. Ten sessions of 1.5 mA real tDCS and 10 sessions of sham tDCS will be administered using Neurocom (Germany) DC stimulator and two 5x7 electrodes, moistened in saline solution, to 10 participants with mTBI following a cross-over design with a 2-week washout period. The location of the brain regions will be determined using either the Transcranial Magnetic Stimulation Neuronavigation or Brainsight Neuronavigation system. The anode will be placed over pre-determined brain regions, whereas the cathode will be placed either over Fp2 (contralateral supraorbital) or other suitable reference areas.
Group II: Healthy ControlsActive Control1 Intervention
Never-concussed age-and gender-matched healthy controls will not receive any intervention. Behavioral and neuroimaging measurements will be administered only once, at the initial visit.

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
247 Previous Clinical Trials
49,522 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
322 Previous Clinical Trials
401,753 Total Patients Enrolled
Ghazala Saleem, EdDPrincipal InvestigatorState University of New York at Buffalo

Media Library

tDCS (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05762796 — N/A
Cognitive Impairment Research Study Groups: Healthy Controls, tDCS in Youth with mild traumatic brain injury
Cognitive Impairment Clinical Trial 2023: tDCS Highlights & Side Effects. Trial Name: NCT05762796 — N/A
tDCS (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05762796 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this clinical trial extend to individuals aged 85 and below?

"This clinical trial permits those between the ages of 10 to 15 to participate. For comparison, there are 198 studies for individuals in the under 18 demographic and 1286 trials enrolling patients over 65 years old."

Answered by AI

Could I be considered for enrollment in this clinical experiment?

"Aspiring participants of this clinical study must fulfil two criteria; they must be between 10 and 15 years old, as well as suffer from some form of motor disorder. This research mandates the recruitment of 10 individuals."

Answered by AI

Are any participants being recruited for this experiment at present?

"This study, which was first listed on June 1st 2023 and last modified on February 27th 2023 is not currently seeking participants. Despite this, however, there are 1536 other medical trials actively recruiting volunteers at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury
Ghazala Tanveer Saleem 2024. "Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05762796.
All > Concussion > Traumatic Brain Injury
~7 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top