Contrastim Stroke Trial

NCT01049802 | Completed Phase 1 Results

• 1 other identifier: NR-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

stroke; hemiplegia; TMS

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline, post treatment, 1 month, 6 months

Secondary Outcomes (4)

• Action Research Arm Test

  Baseline, post treatment, 1 month, 6 months

• Stroke Impact Scale

  Baseline, post treatment, 1 month, 6 months

• Chedoke Arm Assessment

  Screening, baseline, weekly, post treatment, 1 month, 6 months

• NIH Stroke Scale

  Screening, baseline, post treatment, 1 month, 6 months

Study Arms (2)

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.

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

Device: Repetititve transcranial magnetic stimulation

Interventions

Repetititve transcranial magnetic stimulation DEVICE

1 Hz rTMS to contralesional hemisphere in patients with stroke

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Nexstim Ltd: collaborator

Study Sites (1)

The Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Links

• The Rehabilitation Institute of Chicago
• Nexstim Ltd.

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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).

Results Point of Contact

• Title: Richard L. Harvey, MD
• Organization: The Rehabilitation Institute of Chicago

rharvey@ric.org

312-238-1000

Study Officials

• Richard L Harvey, MD

  The Rehabilitation Institute of Chicago

  PRINCIPAL INVESTIGATOR

• Jarmo Laine, MD, PhD, MBA

  Nexstim Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Stroke Rehabilitation

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: September 1, 2016
• Last Updated: December 29, 2016
• Results First Posted: December 29, 2016

Record last verified: 2016-11

Locations

US (1)