StrokeNICHENCT02089464
Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial
A study testing NBS-guided rTMS and Task oriented rehabilitation in people with Stroke, run by Nexstim Ltd at 12 sites in United States.
Trial summary
A pivotal, prospective, multi-center, randomized, controlled, double-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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- NBS-guided rTMS and Task oriented rehabilitation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 12 sitesUnited States
- Study dates
- Apr 2014to May 2016
- 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 or hemorrhagic 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;
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- 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;i
- 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
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Shepherd Rehabilitation Center
Atlanta, Georgia, 30309
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45267
Ohio State University
Columbus, Ohio, 43210
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
Duke University Medical Center
Durham, North Carolina, 27705
TIRR Memorial Hermann Hospital
Houston, Texas, 77030
Indiana University Indianapolis
Indianapolis, Indiana, 46202
Columbia Cornell New York Presbyterian Hospital
New York, New York, 10032
Mayo Clinic
Phoenix, Arizona, 85054
Burke Medical Research Institute, Weill Cornell Neurology
White Plains, New York, 10605
About this study
Official title: Pivotal Phase III, Prospective, Multicenter, Double Blinded, 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 or Hemorrhagic Stroke
A pivotal, prospective, multi-center, randomized, controlled, double-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. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.
- Conditions
- Stroke
- Being tested
- NBS-guided rTMS, Sham rTMS, Task oriented rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBS-guided rTMSDevice
Also called Nexstim
Sham rTMSDevice
Task oriented rehabilitationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| NBS-rTMS + task-oriented rehabilitation | Active comparator | NBS-guided rTMS + task-oriented rehabilitation Receives: Device: NBS-guided rTMS; Procedure: Task oriented rehabilitation |
| Sham rTMS + task-oriented rehabilitation | Sham comparator | Sham rTMS + task-oriented rehabilitation Receives: Device: Sham rTMS; Procedure: Task oriented rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Fugl-Meyer Score
Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID).
Measured: Baseline - 6 months post-treatment
Secondary outcomes (7)
Arm-Research Action Test (ARAT)
Scale minimum 0, maximum 57. Greater values indicate better motor function.
Measured: Baseline - 6 months post-treatment
Wolf Motor Function Test
Time in seconds to perform test tasks. Shorter time indicates better motor function.
Measured: Baseline - 6 months post-treatment
NIH Stroke Scale (NIHSS)
Scale is a measure of neurological functioning, with higher scores reflecting greater deficit (minimum 0,maximum 42)
Measured: Baseline - 6 months post-treatment
Chedoke-McMaster Stroke Assessment (CMSA)
Scale minimum 1, maximum 7. Higher values indicate better motor function of hand.
Measured: Baseline - 6 months post-treatment
Stroke Impact Scale (SIS)
Score used to detect the consequences of stroke on physical functioning and activities of daily living. The SIS-16 is a 16 item survey that inquires about daily tasks performed over the previous 2 weeks. Scale minimum 16, maximum 80. Higher values indicate better function
Measured: Baseline - 6 months post-treatment
Patient Health Questionnaire (PHQ9)
The possible presence and severity of depression will be assessed using the Patient Health Questionnaire (PHQ9). PHQ9 is a scale with a minimum value 0 and maximum of 27. Higher values indicate more depressed mood
Measured: Baseline - 6 months post-treatment
Quality of Life Assessment: EuroQol EQ-5D Scale
The EuroQoL EQ-5D is a visual analog scale scale from 0 (minimum) to 100 (maximum) assessing quality of life. Higher values indicate better quality of life.
Measured: Baseline - 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2016
- Study completionMay 2016
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 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
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nexstim Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard L Harvey, MD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089464
- Sponsor's protocol ID
- NX92325
- Acronym
- NICHE
- Status last verified
- Aug 2020
- First submitted
- 14 Mar 2014
- Last updated
- 1 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Harvey RL, Edwards D, Dunning K, Fregni F, Stein J, Laine J, Rogers LM, Vox F, Durand-Sanchez A, Bockbrader M, Goldstein LB, Francisco GE, Kinney CL, Liu CY; NICHE Trial Investigators *. Randomized Sham-Controlled Trial of Navigated Repetitive Transcranial Magnetic Stimulation for Motor Recovery in Stroke. Stroke. 2018 Sep;49(9):2138-2146. doi: 10.1161/STROKEAHA.117.020607.
PubMed 30354990
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Phase III, Prospective, Multicenter, Double Blinded, 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 or Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT02089464
- Acronym / sponsor ID
- NICHE / NX92325
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Nexstim LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Posted 1 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pivotal, prospective, multi-center, randomized, controlled, double-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. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.
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 |
|---|---|---|
| NBS-rTMS + task-oriented rehabilitation | Active comparator | Device: NBS-guided rTMS, Procedure: Task oriented rehabilitationNBS-guided rTMS + task-oriented rehabilitation |
| Sham rTMS + task-oriented rehabilitation | Sham comparator | Device: Sham rTMS, Procedure: Task oriented rehabilitationSham 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 or hemorrhagic 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 (28 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 |
|---|---|---|
| NBS-guided rTMSAlso: Nexstim | Device | NBS-rTMS + task-oriented rehabilitation |
| Sham rTMS | Device | Sham rTMS + task-oriented rehabilitation |
| Task oriented rehabilitation | Procedure or surgery | NBS-rTMS + task-oriented rehabilitation, Sham rTMS + task-oriented rehabilitation |
Primary outcome
Upper Extremity Fugl-Meyer Score
Time frame: Baseline - 6 months post-treatment
Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID).
7 secondary outcomes
Arm-Research Action Test (ARAT)
Time frame: Baseline - 6 months post-treatment
Wolf Motor Function Test
Time frame: Baseline - 6 months post-treatment
NIH Stroke Scale (NIHSS)
Time frame: Baseline - 6 months post-treatment
Chedoke-McMaster Stroke Assessment (CMSA)
Time frame: Baseline - 6 months post-treatment
Stroke Impact Scale (SIS)
Time frame: Baseline - 6 months post-treatment
Patient Health Questionnaire (PHQ9)
Time frame: Baseline - 6 months post-treatment
Quality of Life Assessment: EuroQol EQ-5D Scale
Time frame: Baseline - 6 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30354990Harvey RL, Edwards D, Dunning K, Fregni F, Stein J, Laine J, Rogers LM, Vox F, Durand-Sanchez A, Bockbrader M, Goldstein LB, Francisco GE, Kinney CL, Liu CY; NICHE Trial Investigators *. Randomized Sham-Controlled Trial of Navigated Repetitive Transcranial Magnetic Stimulation for Motor Recovery in Stroke. Stroke. 2018 Sep;49(9):2138-2146. doi: 10.1161/STROKEAHA.117.020607.
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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.
Richard L Harvey, MD principal investigator
Shirley Ryan AbilityLab
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NBS-guided rTMS and Task oriented rehabilitation in people with Stroke, run by Nexstim Ltd at 12 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 28 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 1 Sep 2020). 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: Baseline - 6 months post-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 NCT02089464, 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 1 Sep 2020.