Electrical Stimulation Therapy for Post-Concussion Syndrome

N/A

Waitlist Available

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

3 or more of the following symptoms: headaches, dizziness, fatigue, irritability, insomnia, concentration, memory difficulty

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 and 4 week follow ups

Awards & highlights

Study Summary

This trial is looking into if electrical stimulation therapy can help improve balance, cognition and symptoms in people with sports-related post-concussion syndrome.

Who is the study for?

This trial is for individuals aged 18-30 who have been diagnosed with a concussion from sports at least one month ago and are experiencing symptoms like headaches, dizziness, or memory issues. They must be able to use a phone, agree to follow the study plan, and be healthy enough as determined by clinical exam.Check my eligibility

What is being tested?

The study tests if cerebellar transcranial direct current stimulation (tDCS) can improve cognition, balance, and reduce symptoms in people with post-concussion syndrome from sports. It checks immediate effects and changes after 2 and 4 weeks.See study design

What are the potential side effects?

While not explicitly mentioned here, tDCS side effects may include mild tingling or itching at the electrode site during application, headache, fatigue or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I experience at least three symptoms like headaches, dizziness, or memory issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 and 4 week follow ups

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 and 4 week follow ups

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 and 4 week follow ups for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Standing Balance Test

Secondary outcome measures

Berg Balance Scale

Dimensional Change Card Sorting Test

Flanker Inhibitory Control Test

+2 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Healthy ControlsActive Control1 Intervention

These will be age and sex-matched healthy controls who only come in for the baseline visit in order to provide comparative values with which to confirm adequate impairment in our diseased population.

Group II: Active GroupActive Control1 Intervention

This group will receive the active form of tDCS. The tDCS will be administered with the anode over the right lobule of the cerebellum, and the cathode over the left lobule of the cerebellum. Stimulation will be administered for a twenty minute period that does not include the 30 second ramp up at the beginning and end of the stimulation.

Group III: Sham GroupPlacebo Group1 Intervention

This group will receive the sham form of tDCS. The electrodes will be placed in the same montage as in the Active group, however the stimulation parameters are different. For this group, the stimulation will be ramped up to the target intensity over thirty seconds at the beginning, then immediately ramp down over thirty seconds. The stimulation will then remain off for the next twenty minutes. After twenty minutes the stimulation will ramp up to the target intensity and then back down over thirty seconds.

0 / 1Eligibility criteria met