NMES + High Protein for Brain Hemorrhage Recovery

Overseen By Neeraj Badjatia, MD MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Trauma, Malignancy, Pregnancy, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 days

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The study purpose is to investigate the hypothesis that in adults with SAH, early neuromuscular electrical stimulation (NMES) and high protein supplementation (HPRO) will improve muscle mass, metabolic and inflammatory biomarker profiles, compared to SAH controls receiving standard of care interventions for nutrition and mobilization. The investigators will accomplish this by studying the effects of a high protein (HPRO) nutritional treatment as well as NMES intervention have upon muscle wasting and motor strength acutely after SAH. This will be addressed in a prospective trial of SAH patients receiving HRPO with NMES as compared to age and severity-matched SAH patients undergoing standard of care interventions for nutrition and mobilization. Additionally, the study will investigate the impact HPRO and NMES interventions have upon inflammatory cytokines and markers of energy balance. Results of this study will establish evidence for precision nutrition plus early exercise to mitigate the catabolic and inflammatory state produced by SAH to improve muscle, metabolic, and health recovery outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment NMES + High Protein for Brain Hemorrhage Recovery?

Research shows that combining neuromuscular electrical stimulation (NMES) with high protein intake can help preserve muscle mass in older adults during periods of inactivity, like bed rest. This suggests that NMES and high protein might help maintain muscle mass during recovery from brain hemorrhage, although it may not improve muscle function. ^{1 2 3 4 5}

Is NMES combined with high protein supplementation safe for humans?

Research shows that combining neuromuscular electrical stimulation (NMES) with high protein supplementation has been studied in various conditions, including critical illness and bed rest in older adults, without significant safety concerns reported. However, the effectiveness and specific safety profile may vary depending on the condition being treated. ^{1 2 3 4 6}

How does the NMES + High Protein treatment differ from other treatments for brain hemorrhage recovery?

The NMES + High Protein treatment is unique because it combines neuromuscular electrical stimulation (NMES) with high-protein supplementation to potentially preserve neuromotor and cognitive function after a brain hemorrhage, unlike standard care which may not focus on these specific interventions. ^{6 7 8 9 10}

Research Team

Neeraj Badjatia, MD

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

Adults aged 25-80 with recent aneurysmal subarachnoid hemorrhage (SAH), who've had aneurysm repair within 48 hours, and will stay in intensive care for over 72 hours. Participants should have a certain severity of SAH but not be too unwell or have conditions like severe kidney issues, muscle disorders, active cancer, or allergies to whey protein.

Inclusion Criteria

You have a Modified Fisher score greater than 1.

I have been diagnosed with a brain aneurysm that has bled.

I am between 25 and 80 years old.

Exclusion Criteria

It's not expected that you will survive for one week after a hemorrhage, either because of severe brain damage or a decision to stop medical treatment.

You are not expected to stay in the intensive care unit for more than 7 days.

You are currently having seizures, as confirmed by clinical assessment or continuous electroencephalogram (cEEG) testing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NMES and/or HPRO interventions to improve muscle mass and metabolic profiles

14 days

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• High Protein Supplementation
• NMES

Trial Overview The trial is testing if early use of neuromuscular electrical stimulation (NMES) and high-protein supplements can help adults after SAH by improving muscle mass and reducing inflammation compared to standard nutrition and mobilization treatments. It's a prospective study matching patients by age and severity.

Participant Groups

Group I: NMES only Experimental Treatment 1 Intervention

Patients will undergo two 30 minute NMES sessions per day during study period.

Group II: HPRO only Experimental Treatment 1 Intervention

Patients will receive HPRO three times daily during study period

Group III: HPRO + NMES Experimental Treatment 2 Interventions

Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.

Group IV: Standard of Care Active Control 1 Intervention

Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Findings from Research

In a study involving 39 ICU patients, the combination of neuromuscular electrical stimulation (NMES), high protein supplementation (HPRO), and physical therapy (PT) significantly reduced lower extremity muscle loss compared to standard ICU care, as evidenced by CT imaging results.

Patients receiving NMES+HPRO+PT experienced less delirium and improved nitrogen balance, indicating better nutritional status, while there were no significant differences in length of stay or days on mechanical ventilation between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining exercise, protein supplementation and electric stimulation to mitigate muscle wasting and improve outcomes for survivors of critical illness-The ExPrES study. Verceles, AC., Serra, M., Davis, D., et al.[2023]

In a study involving 18 healthy elderly men, neuromuscular electrical stimulation (NMES) prior to protein ingestion did not enhance postprandial muscle protein accretion, indicating that it may not improve muscle mass gains after eating.

However, NMES did lead to significant increases in key signaling proteins (mTOR and P70S6K) in the stimulated leg, suggesting that while it may not boost protein synthesis directly, it could still influence muscle signaling pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single session of neuromuscular electrical stimulation does not augment postprandial muscle protein accretion. Dirks, ML., Wall, BT., Kramer, IF., et al.[2019]

In a case study of a 66-year-old woman with a ruptured middle cerebral artery aneurysm, neuromuscular electrical stimulation (NMES) was applied for 10 days but failed to prevent significant muscle wasting in her quadriceps, with thickness reductions of 26% and 35%.

The study suggests that NMES may not be effective in patients with peripheral nerve conduction abnormalities, as indicated by the decreased compound muscle action potential (CMAP) amplitude, which points to the potential presence of critical illness polyneuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation is ineffective for treating quadriceps muscle wasting with ruptured aneurysm: A case report. Nozoe, M., Kamo, A., Shimada, S., et al.[2022]

In a study of 20 healthy older adults undergoing 5 days of bed rest, the combination of neuromuscular electrical stimulation and protein supplementation (NMES+PRO) successfully preserved thigh lean mass despite the negative effects of inactivity.

While NMES+PRO helped maintain muscle mass by reducing markers of muscle atrophy, it did not prevent the decline in muscle function, highlighting the need for additional strategies to address functional loss during bed rest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation Combined with Protein Ingestion Preserves Thigh Muscle Mass But Not Muscle Function in Healthy Older Adults During 5 Days of Bed Rest. Reidy, PT., McKenzie, AI., Brunker, P., et al.[2018]

In a study involving 20 healthy older men, neuromuscular electrical stimulation (NMES) applied before presleep protein ingestion significantly enhanced the incorporation of amino acids into muscle protein during overnight sleep by 18% compared to protein ingestion alone.

This suggests that combining NMES with dietary protein intake can be an effective strategy to counteract muscle atrophy during periods of disuse, such as bed rest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation prior to presleep protein feeding stimulates the use of protein-derived amino acids for overnight muscle protein synthesis. Dirks, ML., Groen, BB., Franssen, R., et al.[2018]

In a study of 25 aneurysmal subarachnoid hemorrhage (SAH) patients, the combination of neuromuscular electrical stimulation (NMES) and high-protein supplementation (HPRO) significantly reduced muscle atrophy compared to standard care, with atrophy rates of 6.5% versus 12.5%.

Patients receiving NMES and HPRO also showed better functional recovery at three months, with improved scores on physical performance and global recovery scales, indicating that this intervention may enhance long-term outcomes after SAH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation and High-Protein Supplementation After Subarachnoid Hemorrhage: A Single-Center Phase 2 Randomized Clinical Trial. Badjatia, N., Sanchez, S., Judd, G., et al.[2022]

In a study of 42 patients recovering from ischaemic stroke, those who received protein supplementation showed a significant improvement in neurological recovery, as measured by the NIH Stroke Scale, compared to those on a standard diet.

The results suggest that higher protein intake is associated with better recovery outcomes, indicating that protein supplementation could be a beneficial intervention in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein supplementation may enhance the spontaneous recovery of neurological alterations in patients with ischaemic stroke. Aquilani, R., Scocchi, M., Iadarola, P., et al.[2016]

In acute stroke patients receiving enteral tube feeding, a leucine-enriched branched-chain amino acid (BCAA) dietary supplement led to quick improvements in serum levels of transthyretin (TTR) and reductions in high-sensitivity C-reactive protein (CRP) within a week, indicating potential benefits for malnutrition management.

Compared to a standard BCAA dietary supplement, the leucine-enriched version showed more favorable changes in TTR and CRP, suggesting it may be a more effective strategy for addressing malnutrition in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quick and effective improvement of leucine enriched dietary supplement on malnutrition in acute stroke patients receiving enteral tube feeding. Mori, T., Yoshioka, K.[2021]

In a study involving 48 male rats with ischemic stroke, an early high-protein diet significantly improved weight gain, reduced neurological impairment, and enhanced motor coordination compared to a standard-protein diet.

The high-protein diet also led to smaller cerebral infarct areas and improved oxidative stress markers, indicating that it may help alleviate the damage caused by ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Early High-protein Diet on Neurofunctional Recovery in Rats with Ischemic Stroke. Ji, M., Li, S., Dong, Q., et al.[2019]

In a study of 50 post-stroke patients over 16 weeks, nutritional supplementation with whey protein and vitamin D did not significantly increase muscle mass or strength, but it did reduce fat infiltration in thigh muscles, which is a positive indicator for muscle quality.

While the supplementation improved some nutritional indicators in the blood, further long-term studies are necessary to determine if these changes lead to better overall recovery and prognosis for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the Effect of Nutritional Supplementation with Whey Protein and Vitamin D on Muscle Mass and Muscle Quality in Subacute Post-Stroke Rehabilitation Patients: A Randomized, Single-Blinded, Placebo-Controlled Trial. Honaga, K., Mori, N., Akimoto, T., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Combining exercise, protein supplementation and electric stimulation to mitigate muscle wasting and improve outcomes for survivors of critical illness-The ExPrES study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A single session of neuromuscular electrical stimulation does not augment postprandial muscle protein accretion. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation is ineffective for treating quadriceps muscle wasting with ruptured aneurysm: A case report. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation Combined with Protein Ingestion Preserves Thigh Muscle Mass But Not Muscle Function in Healthy Older Adults During 5 Days of Bed Rest. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation prior to presleep protein feeding stimulates the use of protein-derived amino acids for overnight muscle protein synthesis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation and High-Protein Supplementation After Subarachnoid Hemorrhage: A Single-Center Phase 2 Randomized Clinical Trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Protein supplementation may enhance the spontaneous recovery of neurological alterations in patients with ischaemic stroke. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Quick and effective improvement of leucine enriched dietary supplement on malnutrition in acute stroke patients receiving enteral tube feeding. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Impact of Early High-protein Diet on Neurofunctional Recovery in Rats with Ischemic Stroke. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Investigation of the Effect of Nutritional Supplementation with Whey Protein and Vitamin D on Muscle Mass and Muscle Quality in Subacute Post-Stroke Rehabilitation Patients: A Randomized, Single-Blinded, Placebo-Controlled Trial. [2022]