StrokePhase 1/2ContraStimNCT01049802

Contrastim Stroke Trial

A Phase 1/2 study testing Repetititve transcranial magnetic stimulation in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Stroke
What is being tested?: Repetititve transcranial magnetic stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Jan 2010to Sep 2016
Phase: Phase 1/2
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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 18 years of age
An ischemic or hemorrhagic stroke suffered 3-9 months prior to the study
no other known brain abnormalities by history or by structural MRI
A one-sided stroke resulting in upper extremity paresis
A Chedoke Arm and Hand Activity Inventory score 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
History of alcohol abuse, illicit drug use or drug abuse or significant mental illness
any history of epilepsy
Any condition that would prevent the subject from giving voluntary informed consent
An implanted brain stimulator

Show all 22Show fewer

Aneurysm clip or other metal in 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
Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in 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 undergoing any other occupational therapy than what is provided in the study
A recent injection of botulinum 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
Ataxia as measured by a score > 1 on item 7 (limb ataxia) 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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Rehabilitation Institute of Chicago
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Evaluation of Therapeutic Effects of Navigation-guided 1 Hz rTMS Administered to the Contralesional Hemisphere in Patients With Stroke

This is a prospective randomized controlled feasibility study to determine whether navigation guided repetitive transcranial magnetic stimulation (rTMS) to the healthy hemisphere in patients with subacute stroke has a beneficial effect when given concurrently with task-oriented motor rehabilitation of the arm and hand. Navigation guided rTMS requires a structural MRI scan for targeting stimulation and therefore structural MRI will be performed on all subjects. In addition the study intends to determine whether measures of motor tract integrity (MTI) assessed by navigated brain stimulation (NBS) and MRI diffusion tensor imaging can be used to clarify prognosis of motor recovery and to monitor progress with rehabilitation. 30 subjects with ischemic or hemorrhagic stroke 3-9 months prior to enrollment and with residual upper limb hemiplegia will be randomized to receive either 1 Hz rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy or sham rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy. Primary outcome is improvement on the Action Research Arm Test, a measure of arm and hand function in people with stroke. Outcomes will be measured immediately post treatment, and at 3 months and 6 months post treatment.

Read the detailed description

PRIMARY OBJECTIVES To determine whether NBS guided 1Hz rTMS targeting the motor representation areas of hand muscles on the healthy brain hemisphere has a beneficial effect on the motor recovery of the corresponding stroke-affected muscles when combined with standardized task-oriented motor rehabilitation.

SECONDARY OBJECTIVES

To determine whether motor evoked potentials (MEPs) can be elicited from paretic and/or plegic muscles in patients with stroke using navigated TMS (eXimia NBS) and targeting the anatomical cortical areas representing the affected muscles.
To determine the correlation between existing MEPs, other TMS parameters and the clinical deficits of limb function.
To determine the prognostic value of MEPs and other TMS parameters in predicting motor recovery after stroke
To determine the diagnostic value of MEPs and other TMS parameters in monitoring the response to rehabilitation
To assess safety by capturing all Serious Adverse Events during both single pulse and rTMS delivery

STUDY PROCEDURES

The purpose of the study including risks and benefits will be explained to potential participants who will then be asked to sign an informed consent form. Potential participants will be screened for inclusion and exclusion criteria

The study will be performed in 2 parts. In part 1 Nexstim eXimia NBS will be utilized for neuronavigation and a third party TMS will be used for delivering the rTMS. In part 2 Nexstim eXimia NBS will be utilized together with Nexstim eXimia TMS for delivering the rTMS. Part 2 will commence once the patients participating in Part 1 have undergone the study visit 22 (see 5.1 below).

15 patients will be recruited to part 1 and 15 patients for part 2 (6 additional subjects will be recruited assuming a 20% drop out rate)

In part 1 of the study 10 subjects will be randomized to rTMS treatment and 5 subjects will be randomized to sham rTMS. Of the 10 rTMS treatment subjects, 5 will be given stimulation protocol A and 5 will be given stimulation protocol B, described below. In part 2, either stimulation protocol A or B will be chosen for continue study based on predetermined outcome criteria. In part 2, 10 subjects will receive this chosen rTMS treatment and 5 subjects will receive sham rTMS.

The study will consist of 24 study visits with the addition of 4 additional visits as needed to complete outcome assessments.

VISIT SCHEDULE

The study will be performed over 24 to 28 sessions:

Visit 1(Screening visit): Baseline = 3-9 months after the stroke. The purpose of this visit is to obtain informed consent for the study (if not previously obtained) and to screen subjects for inclusion and exclusion criteria.
Visit 2: Baseline assessment. The purpose of this visit is to establish the baseline of injury, motor status and NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres - see appendix A). Subjects will also undergo a structural MRI. The subject will then be randomized to either rTMS or to sham treatment. The baseline visit may if necessary take place on 2 separate days.
Visits 3-21: During these visits the patient will undergo standardized task-oriented motor rehabilitation of the hand. In addition the patient will receive the rTMS therapy according to the protocol of the group she/he was randomized into during visit 1. The visits will take place during a 6 week period, three visits per week. During each week the visits will take place each on a separate day and a maximum of two visits will take place on consecutive days. During the first visit of each week (visits 3, 6, 9, 12, 15 and 18) in addition to the rTMS and task-oriented motor rehabilitation, the patient will undergo measurement of NBS parameters (Motor tract integrity, both hemispheres).
Visit 22: End of the task-oriented motor rehabilitation. The purpose of the visit is to establish the extent of recovery that has occurred during the rehabilitation. The visit will take place 3-5 days after the last rTMS/rehabilitation session and includes functional motor testing and evaluation of NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres). 1-2 visits may be needed to complete assessment.
Visit 23: 1 month after the end of the rehabilitation therapy. The purpose of the visit is to determine whether any changes in motor function or NBS parameters have occurred within 1 month of ending therapy. The assessment includes functional motor testing and evaluation of NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres). 1-2 visits may be needed to complete assessment.
Visit 24: 6 months after end of the rehabilitation therapy. The purpose of this visit is to determine the long-term rehabilitation success. The assessment includes functional motor testing and evaluation of NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres. In patients experience a new stroke or TIA during this time, only the data prior to the event will be used in the analysis. 1-2 visits may be needed to complete assessment.

Conditions: Stroke
Being tested: Repetititve transcranial magnetic stimulation
Keywords: stroke, hemiplegia, TMS
Medical subject headings: Stroke, Hemiplegia

What participants receive

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

Repetititve transcranial magnetic stimulationDevice
1 Hz rTMS to contralesional hemisphere in patients with stroke

Study groups in NCT01049802
Study group	Role	What they receive
Active rTMS	Experimental	Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb. Receives: Device: Repetititve transcranial magnetic stimulation
Sham rTMS	Placebo comparator	Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb Receives: Device: Repetititve transcranial magnetic stimulation

What is being measured

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

Upper Extremity Fugl-Meyer Score
Upper extremity Fugl-Meyer Score measures of motor impairment in hemiplegic upper limb of patients with stroke. The scoring follows the natural progression of motor recovery as defined by Twitchell (Brain. 1951; 64:443-480). The score was developed by Axel Fugl-Meyer and it has been validated (Scand J Rehab Med. 1975; 7:13-31; Stroke. 2009; 40: 1386-1391). The scale ranges 0-66 with 66 representing normal motor function and 0 representing no movement. There are 33 movement items each scored 0 (cannot perform), 1 (peforms partially), 2 (performs flawlessly)
Measured: Baseline, post treatment, 1 month, 6 months

Secondary outcomes (4)

Action Research Arm Test
The ARAT is a measure of upper limb dexterity and is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from:
- 3: Performs test normally
- 2: Completes test, but takes abnormally long or has great difficulty
- 1: Performs test partially
- 0: Can perform no part of test Range is 0-57 with higher scores relating to better upper limb dexterity
Measured: Baseline, post treatment, 1 month, 6 months
Stroke Impact Scale
The SIS is a quality of life questionnaire designed for stroke survivors. It is a 59 item measure
- 8 domains assessed:
- Strength (4 items)
- Hand function (5 items)
- ADL/IADL (10 items)
- Mobility (9 items)
- Communication (7 items)
- Emotion (9 items)
- Memory and thinking (7 items)
- Participation/Role function (8 items)
- Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item
- Summative scores are generated for each domain, scores range from 0-100
Measured: Baseline, post treatment, 1 month, 6 months
Chedoke Arm Assessment
A 7 point scale of motor recovery scored separately for arm. 7 is good motor recovery and 1 is no movement.
Measured: Screening, baseline, weekly, post treatment, 1 month, 6 months
NIH Stroke Scale
A composite scale derived from the Toronto Stroke Scale, the Oxbury Initial Severity Scale, the Cincinnati Stroke Scale and the Edinburgh-2 Coma Scale
- 15 items assessing severity of impairment in LOC, ability to respond to questions and obey simple commands, papillary response, deviation of gaze, extent of hemianopsia, facial palsy, resistance to gravity in the weaker limb, plantar reflexes, limb ataxia, sensory loss, visual neglect, dysarthria and aphasia severity
- Items are graded on a 3 or 4 point ordinal scale; 0 equates no impairment
- Scores range from 0 - 42. Higher scores indicate greater severity.
- Stroke severity may be stratified on the basis of NIHSS scores as follows (Brott et al, 1989):
- Very Severe: >25
- Severe: 15 - 24
- Mild to Moderately Severe: 5 - 14
- Mild: 1 - 5
Measured: Screening, baseline, post treatment, 1 month, 6 months

Timeline

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

Jan 2010Sep 2016

First posted14 Jan 2010 (estimated)
Study startJan 2010
Primary completionNov 2013
Study completionSep 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.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01049802
Sponsor's protocol ID: NR-001
Acronym: ContraStim
Status last verified: Nov 2016
First submitted: 13 Jan 2010
Last updated: 29 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
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Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Recruiting
Safety and Feasibility of NRICM301 Added to Usual Care for Adults With Acute Ischemic Stroke
Acute Ischemic Stroke

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Therapeutic Effects of Navigation-guided 1 Hz rTMS Administered to the Contralesional Hemisphere in Patients With Stroke
ClinicalTrials.gov ID: NCT01049802
Acronym / sponsor ID: ContraStim / NR-001
Conditions: Stroke
Keywords: stroke, hemiplegia, TMS
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Shirley Ryan AbilityLabUniversity, hospital or other
Collaborators: Nexstim Ltd
Study start: Jan 2010
Primary completion: Nov 2013 (actual)
Study completion: Sep 2016 (actual)
First posted: 14 Jan 2010 (estimated)
Results: Posted 29 Dec 2016

Clinical summary

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

Detailed description

SECONDARY OBJECTIVES

To determine whether motor evoked potentials (MEPs) can be elicited from paretic and/or plegic muscles in patients with stroke using navigated TMS (eXimia NBS) and targeting the anatomical cortical areas representing the affected muscles.
To determine the correlation between existing MEPs, other TMS parameters and the clinical deficits of limb function.
To determine the prognostic value of MEPs and other TMS parameters in predicting motor recovery after stroke
To determine the diagnostic value of MEPs and other TMS parameters in monitoring the response to rehabilitation
To assess safety by capturing all Serious Adverse Events during both single pulse and rTMS delivery

STUDY PROCEDURES

15 patients will be recruited to part 1 and 15 patients for part 2 (6 additional subjects will be recruited assuming a 20% drop out rate)

The study will consist of 24 study visits with the addition of 4 additional visits as needed to complete outcome assessments.

VISIT SCHEDULE

The study will be performed over 24 to 28 sessions:

Visit 1(Screening visit): Baseline = 3-9 months after the stroke. The purpose of this visit is to obtain informed consent for the study (if not previously obtained) and to screen subjects for inclusion and exclusion criteria.
Visit 2: Baseline assessment. The purpose of this visit is to establish the baseline of injury, motor status and NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres - see appendix A). Subjects will also undergo a structural MRI. The subject will then be randomized to either rTMS or to sham treatment. The baseline visit may if necessary take place on 2 separate days.
Visits 3-21: During these visits the patient will undergo standardized task-oriented motor rehabilitation of the hand. In addition the patient will receive the rTMS therapy according to the protocol of the group she/he was randomized into during visit 1. The visits will take place during a 6 week period, three visits per week. During each week the visits will take place each on a separate day and a maximum of two visits will take place on consecutive days. During the first visit of each week (visits 3, 6, 9, 12, 15 and 18) in addition to the rTMS and task-oriented motor rehabilitation, the patient will undergo measurement of NBS parameters (Motor tract integrity, both hemispheres).
Visit 22: End of the task-oriented motor rehabilitation. The purpose of the visit is to establish the extent of recovery that has occurred during the rehabilitation. The visit will take place 3-5 days after the last rTMS/rehabilitation session and includes functional motor testing and evaluation of NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres). 1-2 visits may be needed to complete assessment.
Visit 23: 1 month after the end of the rehabilitation therapy. The purpose of the visit is to determine whether any changes in motor function or NBS parameters have occurred within 1 month of ending therapy. The assessment includes functional motor testing and evaluation of NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres). 1-2 visits may be needed to complete assessment.
Visit 24: 6 months after end of the rehabilitation therapy. The purpose of this visit is to determine the long-term rehabilitation success. The assessment includes functional motor testing and evaluation of NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres. In patients experience a new stroke or TIA during this time, only the data prior to the event will be used in the analysis. 1-2 visits may be needed to complete assessment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active rTMS	Experimental	Device: Repetititve transcranial magnetic stimulationExperimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
Sham rTMS	Placebo comparator	Device: Repetititve transcranial magnetic stimulationSubject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb

Who may qualify

Ages: 18 to 90 years
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 3-9 months prior to the study
no other known brain abnormalities by history or by structural MRI
A one-sided stroke resulting in upper extremity paresis
A Chedoke Arm and Hand Activity Inventory score of 3-6 for the affected limb

Key exclusion criteria (22 listed)

Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump
Pregnant or trying to become pregnant
History of alcohol abuse, illicit drug use or drug abuse or significant mental illness
any history of epilepsy
Any condition that would prevent the subject from giving voluntary informed consent

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
Repetititve transcranial magnetic stimulation1 Hz rTMS to contralesional hemisphere in patients with stroke	Device	Active rTMS, Sham rTMS

Primary outcome

Upper Extremity Fugl-Meyer Score
Time frame: Baseline, post treatment, 1 month, 6 months
Upper extremity Fugl-Meyer Score measures of motor impairment in hemiplegic upper limb of patients with stroke. The scoring follows the natural progression of motor recovery as defined by Twitchell (Brain. 1951; 64:443-480). The score was developed by Axel Fugl-Meyer and it has been validated (Scand J Rehab Med. 1975; 7:13-31; Stroke. 2009; 40: 1386-1391). The scale ranges 0-66 with 66 representing normal motor function and 0 representing no movement. There are 33 movement items each scored 0 (cannot perform), 1 (peforms partially), 2 (performs flawlessly)

4 secondary outcomes

Action Research Arm Test
Time frame: Baseline, post treatment, 1 month, 6 months
Stroke Impact Scale
Time frame: Baseline, post treatment, 1 month, 6 months
Chedoke Arm Assessment
Time frame: Screening, baseline, weekly, post treatment, 1 month, 6 months
NIH Stroke Scale
Time frame: Screening, baseline, post treatment, 1 month, 6 months

Results and safety

Results posted to the registry on 29 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Contralesional rTMS With Arm Rehabilitation	20	20
Sham Contralesional rTMS Plus Arm Rehabilitation	10	10

Primary outcome: Upper Extremity Fugl-Meyer Score

Time frame: Baseline, post treatment, 1 month, 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Contralesional rTMS With Arm Rehabilitation n = 20	Sham Contralesional rTMS Plus Arm Rehabilitation n = 10
Baseline	23.8 (10.2)	31.5 (15.3)
Post treatment	31.9 (14.6)	37 (18.4)
1 month	32.8 (14.9)	36.1 (18.1)
6 month	37.6 (17.3)	38.6 (16.5)

Contralesional rTMS With Arm Rehabilitation vs Sham Contralesional rTMS Plus Arm Rehabilitation: p = 0.05, Mixed Models Analysis

Population analysed: 6 month outcome is the primary endpoint. 1 data point is missing from the treatment arm at 6 month follow up.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Contralesional rTMS With Arm Rehabilitation	0 of 20 (0%)	6 of 20 (30%)	Not reported
Sham Contralesional rTMS Plus Arm Rehabilitation	2 of 10 (20%)	4 of 10 (40%)	Not reported

Limitations and caveats (from the sponsor): Active group included combination of two types of active rTMS. Data was intended purely for pilot purposes to estimate sample size for a larger multicenter trial (the NICHE clinical trial).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
The Rehabilitation Institute of ChicagoLink provided by the sponsor.
Nexstim Ltd.Link provided by the sponsor.

Related trials for Stroke

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
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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

The Rehabilitation Institute of Chicago

Jarmo Laine, MD, PhD, MBA study director

Nexstim Ltd

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Repetititve transcranial magnetic stimulation in people with Stroke, run by Shirley Ryan AbilityLab at 1 site 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 22 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 29 Dec 2016. 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. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2016). 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, post treatment, 1 month, 6 months). 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 NCT01049802.

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 29 Dec 2016; AzTrials last refreshed its copy on 29 Oct 2026.