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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining early muscle stimulation (NMES, or Neuromuscular Electrical Stimulation) and high-protein supplements can improve recovery in individuals with brain hemorrhages, specifically aneurysmal subarachnoid hemorrhage (SAH). Researchers seek to discover whether these treatments enhance muscle health and reduce inflammation compared to standard care. Participants will be divided into groups to receive NMES, high protein, both, or standard care, allowing measurement of the impact on muscle strength and recovery. This trial suits adults diagnosed with aneurysmal SAH who have undergone repair within 48 hours and are expected to remain in intensive care for more than 72 hours. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could enhance recovery strategies for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that neuromuscular electrical stimulation (NMES) is safe and effective for early rehabilitation. It prevents muscle loss and strengthens muscles in critically ill patients. Studies have found that NMES is easy to tolerate and can reduce pain and stiffness, making it a valuable recovery tool.

High protein supplementation (HPRO) is also generally safe and beneficial for recovery after a brain hemorrhage. A high-protein diet helps maintain muscle strength and improve overall health. Combining HPRO with NMES may further enhance recovery by reducing muscle loss and improving function.

Overall, both NMES and HPRO have been shown to be safe, with studies supporting their use in similar health conditions. Participants can feel reassured that these treatments are well-tolerated and may aid in their recovery process. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the NMES + High Protein treatments for brain hemorrhage recovery because they combine electrical muscle stimulation with high protein supplementation, potentially enhancing muscle recovery and nutritional status simultaneously. Unlike standard treatments that rely primarily on standard rehabilitation and nutrition, NMES specifically targets muscle activation through electrical impulses, while high protein intake supports muscle repair and growth. This dual approach might accelerate recovery by not only improving physical function but also optimizing the body's protein needs, offering a potentially more effective path to rehabilitation for patients.

What evidence suggests that NMES and high protein supplementation could be effective for brain hemorrhage recovery?

Research has shown that neuromuscular electrical stimulation (NMES), one of the treatments in this trial, can aid recovery and improve daily activity performance after a stroke. One study found that NMES was more effective at preventing muscle loss than standard treatments. High protein supplements (HPRO), another treatment option in this trial, have been shown to help maintain muscle strength after a brain bleed and may enhance recovery. This trial will also test the combination of HPRO and NMES, which might help maintain muscle and prevent muscle loss after a specific type of brain bleed called subarachnoid hemorrhage (SAH). Early results suggest that this combination can also positively impact inflammation and energy levels, which are important for recovery. ^{2 3 6 7 8}

Who Is on the Research Team?

Neeraj Badjatia, MD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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 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 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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10680941/

High-Protein Supplementation and Neuromuscular Electric ... A high protein diet (HPRO) combined with neuromuscular electrical stimulation (NMES) attenuates muscle atrophy and may improve functional outcomes after aSAH.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8093316/

A Single Center Phase 2 Randomized Clinical Trial - PMC NMES+HPRO appears to be feasible and safe acutely after SAH, and may reduce acute quadriceps muscle wasting with a lasting benefit on recovery after SAH.

3. withpower.com withpower.com/trial/phase-atrophy-11-2017-3597b

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 ...

4. trialx.com trialx.com/clinical-trials/listings/232686/impact-of-nmes-and-hpro-on-recovery-after-sah-pilot-study/

Impact of NMES and HPRO on Recovery After SAH- Pilot ... Additionally, the study will investigate the impact HPRO and NMES interventions have upon inflammatory cytokines and markers of energy balance.

5. researchgate.net researchgate.net/publication/346652913_Neuromuscular_Electrical_Stimulation_and_High-Protein_Supplementation_After_Subarachnoid_Hemorrhage_A_Single-Center_Phase_2_Randomized_Clinical_Trial

A Single-Center Phase 2 Randomized Clinical Trial Median duration of interventions was 12 days (range 9-14) with completion of 98% of NMES sessions and 83% of goal HPRO, and no reported serious adverse events.

6. mdpi.com mdpi.com/1648-9144/58/9/1264

Early Enteral Nutrition with High-Protein Whey Peptide ... Early Enteral Nutrition with High-Protein Whey Peptide Digestive Nutrients May Improve Prognosis in Subarachnoid Hemorrhage Patients.

7. ahajournals.org ahajournals.org/doi/10.1161/STR.0000000000000436

2023 Guideline for the Management of Patients With ... The 2023 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose, and manage patients with aneurysmal subarachnoid ...

8. researchgate.net researchgate.net/publication/381921724_Identification_of_metabolites_associated_with_preserved_muscle_volume_after_aneurysmal_subarachnoid_hemorrhage_due_to_high_protein_supplementation_and_neuromuscular_electrical_stimulation

(PDF) Identification of metabolites associated with ... Identification of metabolites associated with preserved muscle volume after aneurysmal subarachnoid hemorrhage due to high protein supplementation and ...