학술논문
Randomized, controlled clinical trial of acoustic stimulation to reduce postconcussive symptoms
Document Type
Report
Author
Source
Annals of Clinical and Translational Neurology. January 2024, Vol. 11 Issue 1, p105, 120 p.
Subject
Language
English
Abstract
Introduction Mild traumatic brain injury (mTBI), also known as concussion, has been reported in over 370,000 United States military service members (SMs) since 2000.[sup.1] The actual number may be higher [...]
: Objective: Effective interventions are needed to address postconcussive symptoms. We report the results of randomized, sham‐controlled trial of Cereset Research™ Standard Operating Procedures (CR‐SOP), a noninvasive, closed‐loop, allostatic, acoustic stimulation neurotechnology previously shown to improve insomnia. Methods: Military service members, veterans, or their spouses with persistent symptoms (Neurobehavioral Symptom Inventory [NSI] Score ≥23) after mTBI 3 months to 10 years ago, were randomized to receive 10 sessions of engineered tones linked to brainwaves (LB, intervention), or random engineered tones not linked to brainwaves (NL, sham control). The primary outcome was change in NSI, with secondary outcomes of heart rate variability and self‐report measures of sleep, mood, and anxiety. Results: Participants (n = 106, 22% female, mean age 37.1, 2.8 deployments, 3.8 TBIs) were randomized 1:1 to LB or NL, with no significant differences between groups at baseline. Among all study participants, the NSI declined from baseline 41.0 to 27.2 after (P < 0.0001), with gains largely sustained at 3 months (31.2) and 6 months (28.4). However, there were no significant differences between the LB (NSI declined from 39.9 at baseline to 28.2 post‐intervention, 31.5 at 3 months, and 29.4 at 6 months) and NL (NSI declined from 41.5 at baseline to 26.2, 29.9, and 27.3, respectively. Similar patterns were observed for the PCL5 and PHQ‐9 and there was no difference in HRV between groups. Interpretation: Ten hours of acoustic stimulation while resting in a zero‐gravity chair improves postconcussive symptoms. However, linking tones to brain electrical activity did not reduce symptoms more than random tones. Registration: ClinicalTrials.gov – NCT03649958
: Objective: Effective interventions are needed to address postconcussive symptoms. We report the results of randomized, sham‐controlled trial of Cereset Research™ Standard Operating Procedures (CR‐SOP), a noninvasive, closed‐loop, allostatic, acoustic stimulation neurotechnology previously shown to improve insomnia. Methods: Military service members, veterans, or their spouses with persistent symptoms (Neurobehavioral Symptom Inventory [NSI] Score ≥23) after mTBI 3 months to 10 years ago, were randomized to receive 10 sessions of engineered tones linked to brainwaves (LB, intervention), or random engineered tones not linked to brainwaves (NL, sham control). The primary outcome was change in NSI, with secondary outcomes of heart rate variability and self‐report measures of sleep, mood, and anxiety. Results: Participants (n = 106, 22% female, mean age 37.1, 2.8 deployments, 3.8 TBIs) were randomized 1:1 to LB or NL, with no significant differences between groups at baseline. Among all study participants, the NSI declined from baseline 41.0 to 27.2 after (P < 0.0001), with gains largely sustained at 3 months (31.2) and 6 months (28.4). However, there were no significant differences between the LB (NSI declined from 39.9 at baseline to 28.2 post‐intervention, 31.5 at 3 months, and 29.4 at 6 months) and NL (NSI declined from 41.5 at baseline to 26.2, 29.9, and 27.3, respectively. Similar patterns were observed for the PCL5 and PHQ‐9 and there was no difference in HRV between groups. Interpretation: Ten hours of acoustic stimulation while resting in a zero‐gravity chair improves postconcussive symptoms. However, linking tones to brain electrical activity did not reduce symptoms more than random tones. Registration: ClinicalTrials.gov – NCT03649958