Utilization and Perceived Benefit of Alpha Stim in Service Members and Veterans with Traumatic Brain Injury

Introduction: Traumatic Brain Injury is a major healthcare concern within the Department of Defense and Department of Veterans Affairs. According to the TBI Center of Excellence, 82% of TBIs experienced by service members (SM) are considered mild. Mild TBI (mTBI) can result in chronic comorbid physical, behavioral, sleep and cognitive symptoms. For Veterans and SM with TBI, research has demonstrated that they are 2-3 times more likely to develop a comorbid mental health condition such as PTSD, anxiety, depression than those without a TBI. As compared to CF, SOF personnel are at increased risk for sustaining multiple TBIs, and have a higher suicide risk. There are limited evidence-based non-pharmacological interventions available to the SOF community to effectively and efficiently treat chronic symptom cluster associated with multiple TBI’s.
Non-pharmacological interventions (NPI) are sought after to reduce chronic physical, behavioral, cognitive and sleep deficiencies following repeated TBI exposure. Alpha Stim® is a CES prescriptive, noninvasive electromedical device that delivers a pulsed microcurrent via small ear clips or through hand-held probes. Alpha Stim® is FDA cleared for use in the treatment of insomnia, anxiety, and pain. Increasingly, mTBI providers have begun to utilize this modality for a wide range of post-concussive symptoms. Given both it’s potential of symptom management and increased requests within the SOF community, USSOCOM identified a need for further evaluation of clinical utility and outcomes of using cranial electrostimulation (CES) in individuals with TBI.
The Post deployment Rehabilitation and Evaluation Program (PREP), is a comprehensive inpatient TBI rehabilitation program at James Haley VA Hospital. Participants have a complex history of multiple TBI’s, alongside numerous musculoskeletal, sensory, cognitive and mental health co-morbidities. As part of PREP, Alpha Stim® devices are issued to patients for use during their rehabilitation in order to reduce/modulate symptoms of mTBI and associated comorbidities.
Study results presented will include the clinical approaches and practices of practitioners delivering Alpha Stim® devices to those with TBI.

Methods: This study was reviewed and approved by the James A Haley Research and Development Review Board and University of South Florida Bulls IRB (STUDY003283). In a mixed methods, prospective study design, participants were recruited, consented and enrolled from PREP at JAHVA from 2022-2023. Target enrolment was set at 120. Enrolled PREP participants were followed during typical standard of care. Outcomes of interest were collected as part of their program participation and included anxiety (GAD-7), depression, (PHQ-9), pain, (PROMIS-Pain Interference and pain medication use), headaches (HIT-6), dizziness (DHI), and family relationships (M2PAI). Participants were issued a CES device and trained by a Alpha Stim® certified Occupational and / or Physical Therapist, and followed during their admission. Typical training for the CES device included a group session, “Mixed Modality Academy (MMA)” where participants were instructed on the use and application of CES as well as other modalities. Follow-up sessions were done with the Occupational Therapist for further device training or general rehabilitation needs post TBI. Participants were issued logbooks to track Alpha Stim® use, parameters, targeted symptoms and targeted symptoms. A brief semi structured interview inquired about participants training with device, continued use/non-use of device, and device use impact on symptoms. To further understand clinician perspectives, anonymous survey was distributed to polytrauma and rehabilitation clinicians related list servs to gain clinical insight into use of device.

Results: Demographics-
119 subjects with at least 1 medically documented TBI were consented into the study (note: although the number of TBI’s was not recorded in this study, PREP participants are described elsewhere in the literature). Subjects were on average 46 year old, predominantly male (99.2%) and 70% of participants did not state their race/ethnicity was white (25.2%), black (1.7%), Hispanic (.8). Baseline scores on self-reported measures included severe anxiety in 26.9%, PCL-5 scores above 33 in 51.7% , severe depression reported in 9.2% and severe pain interfering with life and function in 10.3% of the sample. Participant reported average pain scale of 3.79 (SD 2.12)
Logbooks: Of 47/49 participants that logged primary symptom: 30 (63.8%) used for headache, 22 (46.8%) used for sleep issues, 22 (46.8%) used for non-headache pain, 15 (31.9%) used for anxiety. Symptom improvement averaged 1 point on 0-10 scale per treatment. Symptom changes declined over time, likely due to change in initial symptom intensity. Small numbers of participants used Alpha-Stim for anger (n = 2, 4.3%), depression (n = 2), irritability (n = 1, 2.1%), or other reasons (n = 7, 14.9%).
Dose response relationship: Analysis of logs indicated participants used the recommended settings (0.5Hz) as well as a higher frequency of 1.5 Hz. Treatment time was generally as per manufacturer recommendation, with the exception of sleep, time tended to be higher (mean time 29.86 minutes)
Differences in those who continued to use the device vs not use the device: PTSD self-reported measure (PCL-5) was the only outcome measures that demonstrated a significant difference between those continuing and those not continuing. Subject not continuing to use Alpha-Stim were 0.5 standard deviation lower in their PCL-5 score upon admission.
Patient interviews: Thematic analyses, based on descriptive phenomenology was used to analyze the semi-structured interview data. Eight-one (81) qualitative interviews identified barriers and facilitators to using Alpha-Stim.. Development of a prescriptive treatment plan, tracking levels of intensity at various time markers can be helpful to clinicians and patients. Perceived benefits such as relaxation and troubleshooting could increase participant usage and continued use of the AS device. Of the 65 participants who self-reported experiencing anxiety/depression, 35 found Alpha-Stim helped with these symptoms, 5 were unsure, and 7 did not use Alpha-Stim for anxiety or depression, demonstrating both the benefits of the device and missed opportunities to enhance its use among service members and veterans.
Study participants were interviewed following discharge regarding perceived benefits, barriers and facilitators to using CES. Of the 81 individuals interviewed, 60 (73%) continued to use Alpha-Stim CES following discharge. Participants indicated benefit from use of the device related to pain (49%). anxiety/depression (44%), and sleep (40%),
Primary barriers to continued CES use included when participants combined CES with other symptom management strategies (ex. meditation, or , which made it unclear to users if CES was providing actual relief. An additional barrier to continued use was users felt they lacked a clear plan of use, often described as not knowing the end point to the device, if they were to continue to use it “forever”. In addition, to perceived direct symptom relief from CES, a common facilitator to continued CES use included being able to trouble shoot device use for symptom management.
Clinician survey: Analysis of clinician surveys (n=35)revealed providers tend to prescribe Alpha-Stim® to patient with TBI for treatment and / or symptom reduction in anxiety (19), insomnia/ sleep (17), headache/migraine (17) and pain (15). Clinicians indicated that they provide 1-2 session of Alpha-Stim training. Overall, participants were satisfied with the training received. This demonstrates a low burden for clinician to integrate into patient treatment plan. Overall, clinicians tended to agree with all statements, with the large majority of responses being 3, 4, or 5. Clinicians agreed most with the statement, “I feel adequately prepared to train, educate and use Alpha,” with most (14 out of 19) responding with a 4 or 5. Clinicians agreed almost as much with the statement, “I feel that I am able to verbally communicate effectively and appropriately how to use Alpha,” also with most (14 out of 19) responding with a 4 or 5. The statements with the least agreement were related to treatment planning (i.e., Statements 3, 4, and 7).

Discussion: The use of Alpha Stim in a cohort of active duty service members and veterans with mTBI shows promising results in the management of symptoms related to TBI and typical comorbidities of pain, headache, sleep, anxiety and depression. Although some felt cognitive improvement were secondary benefit (ex. reported relief in sleep, which helped memory and thinking), none reported direct cognitive improvements. The use of Alpha-Stim does not appear to weaken its effect over time, suggesting clinicians may instruct patients to use the device as an abortive treatment or as a preventative for their trigger symptom. Alpha Stim training appears to be a low burden to integrate into a patients treatment planning, and as with many modalities, a perceived benefit in symptoms reduction tends to motivate behavior changes constructs across multiple frameworks.

Conclusion: Non-Pharmacological Interventions (NPI) are areas of particular interest in the management of chronic disease and especially in the military as NPI hold less stigma compared to medication and psychotherapy. The need for quality research on NPI such as CES is highlighted in the Clinical Practice Guidelines for the management of headache and TBI. Given the risk for chronic illness, suicide, those with multiple TBI exposures, especially SOF, the need for additional research on CES effectiveness is highlighted. Alpha-Stim shows potential to be a beneficial non-pharmacological intervention for treatment of mTBI symptoms including sleep difficulty, anxiety, headache pain, and non-headache pain. Improvement in one or more of these TBI-related symptoms can also support family and quality of life.