Ischemic StrokeE-FITNCT03010462

Electric Field Navigated 1hz Rtms for Post-stroke Motor Recovery Trial

A study testing Nexstim NBS guided active rTMS in people with Ischemic Stroke, run by Nexstim Ltd at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A prospective, multi-center, randomized, sham-controlled, blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment of the upper limb. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Stroke
What is being tested?: Nexstim NBS guided active rTMS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 5 sitesUnited States
Study dates: 1 Mar 2017to 15 Aug 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

≥ 18 years of age
An ischemic stroke suffered 3-12 months prior to the study
No other known brain abnormalities by history;
A one-sided stroke resulting in upper extremity paresis
A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb

Who cannot join

Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.
Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial.
History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months.
Any condition that would prevent the subject from giving voluntary informed consent;

Show all 27Show fewer

An implanted brain stimulator;
Any metal in head with the exception of dental work or any ferromagnetic metal -elsewhere in the body;
Enrolled or plans to enroll in an interventional trial during this study;
Scalp wounds or infections;
Claustrophobia precluding MRI;
A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact;
Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;
Previous stroke with residual deficits (TIAs not a reason for exclusion);
Premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology;
A concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition,
Confirmed or suspected lower-limb fracture preventing mobilization, patients requiring palliative care
Patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study
A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up.
A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up.
Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale.
Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale.
Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.
Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale.
Patients unable to comprehend or follow verbal commands
Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition
A Mini mental status exam (MMSE) <25.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45267
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
Burke Medical Research Institute, Weill Cornell Neurology
White Plains, New York, 10605

Other trials in United States

About this study

Official title: A Prospective, Multi-center, Randomized, Sham-controlled Trial to Determine the Therapeutic Effects of Navigation Guided 1 hz Rtms Administered to the Contralesional Hemisphere as Adjuvant to Task-oriented Rehabilitation in Patients With Ischemic Stroke

Conditions: Ischemic Stroke
Being tested: Nexstim NBS guided active rTMS, Nexstim NBS guided sham rTMS
Keywords: Stroke, rTMS, Motor rehabilitation
Medical subject headings: Ischemic Stroke, Stroke

What participants receive

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

Nexstim NBS guided active rTMSDevice
Nexstim NBS guided active rTMS + standardized task-oriented therapy
Nexstim NBS guided sham rTMSDevice
Nexstim NBS guided sham rTMS + standardized task-oriented therapy

Study groups in NCT03010462
Study group	Role	What they receive
Active	Active comparator	Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation Receives: Device: Nexstim NBS guided active rTMS
Control	Sham comparator	Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation Receives: Device: Nexstim NBS guided sham rTMS

What is being measured

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

Upper Extremity Fugl-Meyer Score
Range 0 to 65. HIgher scores indicate better function. Minimal clinically important difference = change of 5 points or more on scale. Outcome measure = proportion of patients in treatment arm gaining at least 5 points on scale between baseline and 6 months after end of treatment.
Measured: Change from baseline to 6 months after end of treatment.

Secondary outcomes (4)

Upper Extremity Fugl-Meyer Score
Range 0-65. HIgher scores indicate better function.
Measured: Change in score from baseline to 6 months after end of treatment
Arm-Research Action Test (ARAT)
Range 0 to 57. Higher scores indicate better function.
Measured: Change in score from baseline to 6 months after end of treatment.
NIH Stroke Scale (NIHSS)
National Institute of Health Stroke Scale - Motor Arm. Range 0 to 4. Lower score indicates better function.
Measured: Change in score from baseline to 6 months after end of treatment
Quality of Life Assessment: EQ-5D
EuroQoL - EQ-5D score. Range 0 to 100. HIgher numbers indicate better quality of life.
Measured: Change in score from baseline to 6 months after end of treatment

Timeline

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

1 Mar 201715 Aug 2018

First posted5 Jan 2017 (estimated)
Study start1 Mar 2017
Primary completion15 Aug 2018
Study completion15 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03010462
Sponsor's protocol ID: NX103391
Acronym: E-FIT
Status last verified: Mar 2021
First submitted: 3 Jan 2017
Last updated: 26 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Edwards DJ, Liu CY, Dunning K, Fregni F, Laine J, Leiby BE, Rogers LM, Harvey RL. Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial. Stroke. 2023 Sep;54(9):2254-2264. doi: 10.1161/STROKEAHA.123.043164. Epub 2023 Aug 14.
PubMed 37577801

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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 locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Randomized, Sham-controlled Trial to Determine the Therapeutic Effects of Navigation Guided 1 hz Rtms Administered to the Contralesional Hemisphere as Adjuvant to Task-oriented Rehabilitation in Patients With Ischemic Stroke
ClinicalTrials.gov ID: NCT03010462
Acronym / sponsor ID: E-FIT / NX103391
Conditions: Ischemic Stroke
Keywords: Stroke, rTMS, Motor rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Nexstim LtdIndustry (pharma, biotech, devices)
Study start: 1 Mar 2017 (actual)
Primary completion: 15 Aug 2018 (actual)
Study completion: 15 Aug 2018 (actual)
First posted: 5 Jan 2017 (estimated)
Results: Posted 26 Apr 2021

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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active	Active comparator	Device: Nexstim NBS guided active rTMSIntervention: Device: NBS-guided rTMS + task-oriented rehabilitation
Control	Sham comparator	Device: Nexstim NBS guided sham rTMSIntervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation

Who may qualify

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

Key inclusion criteria (5 listed)

≥ 18 years of age
An ischemic stroke suffered 3-12 months prior to the study
No other known brain abnormalities by history;
A one-sided stroke resulting in upper extremity paresis
A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb

Key exclusion criteria (27 listed)

Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.
Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial.
History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months.

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
Nexstim NBS guided active rTMSNexstim NBS guided active rTMS + standardized task-oriented therapy	Device	Active
Nexstim NBS guided sham rTMSNexstim NBS guided sham rTMS + standardized task-oriented therapy	Device	Control

Primary outcome

Upper Extremity Fugl-Meyer Score
Time frame: Change from baseline to 6 months after end of treatment.
Range 0 to 65. HIgher scores indicate better function. Minimal clinically important difference = change of 5 points or more on scale. Outcome measure = proportion of patients in treatment arm gaining at least 5 points on scale between baseline and 6 months after end of treatment.

4 secondary outcomes

Upper Extremity Fugl-Meyer Score
Time frame: Change in score from baseline to 6 months after end of treatment
Arm-Research Action Test (ARAT)
Time frame: Change in score from baseline to 6 months after end of treatment.
NIH Stroke Scale (NIHSS)
Time frame: Change in score from baseline to 6 months after end of treatment
Quality of Life Assessment: EQ-5D
Time frame: Change in score from baseline to 6 months after end of treatment

Results and safety

Results posted to the registry on 26 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active	31	28
Control	29	28

Primary outcome: Upper Extremity Fugl-Meyer Score

Time frame: Change from baseline to 6 months after end of treatment.. Count of participants. Unit: Participants

Measure	Active n = 30	Control n = 28
Value	18	14

Active vs Control: p = 0.62, Chi-squared, Corrected

Population analysed: Intent to treat population. All subjects completing the baseline visit.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline until 6 months after end of treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	4 of 30 (13.3%)	5 of 30 (16.7%)	0 of 30
Control	5 of 28 (17.9%)	2 of 28 (7.1%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37577801Edwards DJ, Liu CY, Dunning K, Fregni F, Laine J, Leiby BE, Rogers LM, Harvey RL. Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial. Stroke. 2023 Sep;54(9):2254-2264. doi: 10.1161/STROKEAHA.123.043164. Epub 2023 Aug 14.
Individual participant dataSharing planned: No

Related trials for Ischemic Stroke

Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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Not yet recruiting
Accelerated Theta-Burst Stimulation for Refractory Central Post-Stroke Pain
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Nexstim NBS guided active rTMS in people with Ischemic Stroke, run by Nexstim Ltd at 5 sites in United States.

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 5 inclusion and 27 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: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 26 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Upper Extremity Fugl-Meyer Score (time frame: Change from baseline to 6 months after end of treatment.). 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 NCT03010462, which also lists 1 linked publication.

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 26 Apr 2021.