The Effects of Synaquell on Brain Function of Ice Hockey Players
- Conditions
- Healthy
- Registration Number
- NCT05498818
- Lead Sponsor
- Mayo Clinic
- Brief Summary
This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth ice hockey players.
- Detailed Description
This randomized clinical trial will compare a brain health supplement (Synaquell) with placebo in both male and female ice hockey players over the course of an entire season. The repeated measure design will compare pre- and post-season objective brain health parameters, including quantitated EEG (Neurocatch), blood biomarkers and a rapid number naming test (King Devick).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- Fluent English speakers
- Medically cleared to play ice hockey
- An allergy to the ingredients of SynaquellTM or the placebo
- Clinically documented hearing issues,
- In-ear hearing aid or cochlear implant
- Implanted pacemaker or defibrillator
- Metal or plastic implants in skull
- Lack of verbal fluency in the English language
- History of seizures
- Allergy to rubbing alcohol or EEG gel
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in N100 Amplitude Baseline, Postseason (approximately 6 months) Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Change in P300 Amplitude Baseline, Postseason (approximately 6 months) Obtained by EEG recording of P300 potential amplitude. Increased amplitudes are indicative of larger signals. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Change in P300 Latency Baseline, Postseason (approximately 6 months) Obtained by EEG recording of P300 potential latency. Increased latencies are indicative of slower responses. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Change in N400 Amplitude Baseline, Postseason (approximately 6 months) Obtained by EEG recording of N400 potential amplitude. Increased amplitudes are indicative of larger signals.This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Change in blood biomarker Baseline, Postseason (approximately 6 months) Neurofilament light chain (NfL) blood serum levels
Change in N400 Latency Baseline, Postseason (approximately 6 months) Obtained by EEG recording of N400 potential latency. Increased latencies are indicative of slower responses.This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Change in N100 Latency Baseline, Postseason (approximately 6 months) Obtained by EEG recording of N100 potential latency. Increased latencies are indicative of slower responses. Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
- Secondary Outcome Measures
Name Time Method Change in King-Devick Test (KDT) scores Baseline, Postseason (approximately 6 months) A rapid number-naming test that requires individuals to read 3 numbered patters aloud as fast as possible, the resulting time if the KDT score. The post-season score is compared to the pre-season baseline. An increase in the number of seconds required to read the 3 number patterns is considered to be significant.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Mayo Clinic in Rochester🇺🇸Rochester, Minnesota, United States