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Contrastim Stroke Trial (ContraStim)

This study has been completed.
Sponsor:
Collaborator:
Nexstim Ltd
Information provided by (Responsible Party):
Richard Harvey, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01049802
First received: January 13, 2010
Last updated: November 2, 2016
Last verified: November 2016
Results First Received: July 31, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stroke
Intervention: Device: Repetititve transcranial magnetic stimulation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Contralesional rTMS With Arm Rehabilitation

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.

repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke

Sham Contralesional rTMS Plus Arm Rehabilitation

Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb

repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke


Participant Flow:   Overall Study
    Contralesional rTMS With Arm Rehabilitation   Sham Contralesional rTMS Plus Arm Rehabilitation
STARTED   20   10 
COMPLETED   20   10 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Contralesional rTMS With Arm Rehabilitation

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.

repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke

Sham Contralesional rTMS Plus Arm Rehabilitation

Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb

repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke

Total Total of all reporting groups

Baseline Measures
   Contralesional rTMS With Arm Rehabilitation   Sham Contralesional rTMS Plus Arm Rehabilitation   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   10   30 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      15  75.0%      8  80.0%      23  76.7% 
>=65 years      5  25.0%      2  20.0%      7  23.3% 
Age 
[Units: Years]
Mean (Full Range)
 59.0 
 (22 to 90) 
 48.1 
 (20 to 74) 
 55.3 
 (20 to 90) 
Gender 
[Units: Participants]
Count of Participants
     
Female      8  40.0%      5  50.0%      13  43.3% 
Male      12  60.0%      5  50.0%      17  56.7% 
Fugl-Meyer Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 23.8  (10.2)   31.5  (15.3)   26.4  (12.4) 
[1] 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)


  Outcome Measures
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1.  Primary:   Upper Extremity Fugl-Meyer Score   [ Time Frame: Baseline, post treatment, 1 month, 6 months ]

2.  Secondary:   Action Research Arm Test   [ Time Frame: Baseline, post treatment, 1 month, 6 months ]

3.  Secondary:   Stroke Impact Scale   [ Time Frame: Baseline, post treatment, 1 month, 6 months ]

4.  Secondary:   Chedoke Arm Assessment   [ Time Frame: Screening, baseline, weekly, post treatment, 1 month, 6 months ]

5.  Secondary:   NIH Stroke Scale   [ Time Frame: Screening, baseline, post treatment, 1 month, 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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).


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Richard L. Harvey, MD
Organization: The Rehabilitation Institute of Chicago
phone: 312-238-1000
e-mail: rharvey@ric.org



Responsible Party: Richard Harvey, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01049802     History of Changes
Other Study ID Numbers: NR-001
Study First Received: January 13, 2010
Results First Received: July 31, 2015
Last Updated: November 2, 2016