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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

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).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Changes in GAD-7

Changes in PHQ-8

Changes in WASI-II

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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