Subarachnoid HemorrhageNCT03201094

Impact of NMES and HPRO on Recovery After SAH- Pilot Study

A study testing Neuromuscular Electrical Stimulation (NMES) and High Protein Supplementation in people with Subarachnoid Hemorrhage and Muscle Atrophy, run by University of Maryland, Baltimore at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Subarachnoid Hemorrhage, Muscle Atrophy, Inflammation
What is being tested?: Neuromuscular Electrical Stimulation (NMES) and High Protein Supplementation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2017to 30 Oct 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

. Being diagnosed with aneurysmal SAH
. Aneurysmal repair within 48 hours of ictus.
. Age between 25 and 80 years old. (>=25 years old and <=80 years old)
. Expected stay in the NCCU > 72 hours.
. Admission Hunt Hess Grade >=2.
modified Fisher score >1.

Who cannot join

. Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes;
. Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care;
. Unlikely to remain in the ICU for more than 7 days;
. Body mass index < 15 or >40 kg/m2;
. Allergy to whey protein;
. Evidence of lower extremity paresis or spasticity within 48 hours of injury

Show all 15Show fewer

. Pre-morbid modified Rankin Score >1.
. Known pregnancy
. Presence of active malignancy
. Diagnosis of an inflammatory disorder
. Presence of a neuromuscular disorder
. Diagnosis of chronic renal insufficiency or acute kidney injury (GFR < 30 mL/min/1.73m2)
. Hepatic insufficiency defined as AST/ALT levels >2.5 above normal upper limits.
. On-going seizure activity as assessed clinically or by electrographic detection on continuous electroencephalogram (cEEG) at time of enrollment
. Prisoner.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Neeraj Badjatia, MD MSc contact

4103284515

nbadjatia@umm.edu

United States1 site, 1 recruiting

University of Maryland Medical Center
Baltimore, Maryland, 21201
Neeraj Badjatia, MD MS, 4103284515, nbadjatia@umm.edu
Recruiting

Other trials in United States

About this study

Official title: Impact of Neuromuscular Stimulation and High Protein Nutritional Supplementation on Long-term Recovery After Aneurysmal Subarachnoid Hemorrhage.

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.

Conditions: Subarachnoid Hemorrhage, Muscle Atrophy, Inflammation, Nutritional and Metabolic Disease
Being tested: Neuromuscular Electrical Stimulation (NMES), High Protein Supplementation
Medical subject headings: Subarachnoid Hemorrhage, Muscular Atrophy, Inflammation, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neuromuscular Electrical Stimulation (NMES)Device
Neuromuscular electrical stimulation twice daily during study period.
High Protein SupplementationDietary supplement
High protein supplementation with whey protein shakes taken three times a day during study period.

Study groups in NCT03201094
Study group	Role	What they receive
Standard of Care	No intervention	Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.
HPRO + NMES	Experimental	Patients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM. Receives: Device: Neuromuscular Electrical Stimulation (NMES); Dietary Supplement: High Protein Supplementation
NMES only	Experimental	Patients will undergo two 30 minute NMES sessions per day during study period. Receives: Device: Neuromuscular Electrical Stimulation (NMES)
HPRO only	Experimental	Patients will receive HPRO three times daily during study period Receives: Dietary Supplement: High Protein Supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period.
Change in the muscle layer thickness of the quadriceps muscle as measured by ultrasound.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201730 Oct 2026

First posted28 Jun 2017
Study start1 Dec 2017
Primary completion30 Sep 2026 (estimated)
Study completion30 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03201094
Sponsor's protocol ID: HP-00074174
Status last verified: Sep 2026
First submitted: 23 Jun 2017
Last updated: 4 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Interested in taking part?

Neeraj Badjatia, MD MSc

4103284515

nbadjatia@umm.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke

All Subarachnoid Hemorrhage trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Neuromuscular Stimulation and High Protein Nutritional Supplementation on Long-term Recovery After Aneurysmal Subarachnoid Hemorrhage.
ClinicalTrials.gov ID: NCT03201094
Acronym / sponsor ID: HP-00074174
Conditions: Subarachnoid Hemorrhage, Muscle Atrophy, Inflammation, Nutritional and Metabolic Disease
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Study start: 1 Dec 2017 (actual)
Primary completion: 30 Sep 2026 (estimated)
Study completion: 30 Oct 2026 (estimated)
First posted: 28 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Standard of Care	No intervention	–Patients will receive standard of care mobilization and nutritional supplementation throughout the study period.
HPRO + NMES	Experimental	Device: Neuromuscular Electrical Stimulation (NMES), Dietary Supplement: High Protein SupplementationPatients will receive high protein supplementation(HPRO) administered within 30 minutes after each NMES session and additionally once at approximately 10 PM.
NMES only	Experimental	Device: Neuromuscular Electrical Stimulation (NMES)Patients will undergo two 30 minute NMES sessions per day during study period.
HPRO only	Experimental	Dietary Supplement: High Protein SupplementationPatients will receive HPRO three times daily during study period

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

. Being diagnosed with aneurysmal SAH
. Aneurysmal repair within 48 hours of ictus.
. Age between 25 and 80 years old. (>=25 years old and <=80 years old)
. Expected stay in the NCCU > 72 hours.
. Admission Hunt Hess Grade >=2.

Key exclusion criteria (15 listed)

. Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes;
. Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care;
. Unlikely to remain in the ICU for more than 7 days;
. Body mass index < 15 or >40 kg/m2;
. Allergy to whey protein;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neuromuscular Electrical Stimulation (NMES)Neuromuscular electrical stimulation twice daily during study period.	Device	HPRO + NMES, NMES only
High Protein SupplementationHigh protein supplementation with whey protein shakes taken three times a day during study period.	Dietary supplement	HPRO + NMES, HPRO only

Primary outcome

Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period.
Time frame: 14 days
Change in the muscle layer thickness of the quadriceps muscle as measured by ultrasound.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Subarachnoid Hemorrhage

Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Neeraj Badjatia, MD MSc contact

4103284515

nbadjatia@umm.edu

Neeraj Badjatia, MD MSc principal investigator

University of Maryland, Baltimore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Neeraj Badjatia, MD MSc (4103284515, nbadjatia@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in muscle layer thickness of the quadriceps muscle as measured by muscle ultrasound scan at the end of study period. (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03201094.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.