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Investigating Motor Cortex Processing for Pain Modulation

This study has been terminated.
(Study was halted due to lack of funding.)
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01404039
First received: June 29, 2011
Last updated: March 14, 2017
Last verified: March 2017
Results First Received: April 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Investigator, Outcomes Assessor;   Primary Purpose: Basic Science
Condition: Motor Activity
Interventions: Behavioral: Motor Learning
Behavioral: Somatosensory Learning
Behavioral: Observational Task
Behavioral: Mental Imagery
Device: transcranial direct current 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
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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
Motor Learning - MLsighted/MLblind/MLcontrol This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
Motor Learning (ML) MLblind/MLcontrol/MLsighted This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
Motor Learning (ML) MLcontrol Group/MLsighted/MLblind This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
Somatosensory Learning (SL Sighted)

In this arm, subject will perform sensory Learning with visual feedback - SL sighted.

There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).

Somatosensory Learning (SL Blind)

In this arm, subject will perform sensory Learning without visual feedback - SL blind.

There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).

Somatosensory Activation (S Activation)

In this arm, subject will receive simple sensory stimulation over their left index finger - Sactivation.

There will be an anticipated total of 10 subjects in this experimental arm.This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).

Somatosensory Learning (SL) Control Group

In this arm,the subjects will not receive any somatosensory input (SL control group).

There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).

Observational Task (OT) Observational Task: Subjects in this group will watch a 10 second video of a right-handed person performing movements of their left index finger at a 1 Hz rate on a screen at a distance of 1 meter away. Subjects will be instructed to watch the video without any other specific instruction.
Observational Task (OT) - Control Group Control Group -- Observational Task: Subjects in this group will be asked to watch a video of random geometric forms for the same duration of time as those in the observational task group.
Mental Imagery (MI) Mental Imagery: Subjects will be seated in a chair and are asked to keep their arm and hand muscles fully relaxed. Then they will be asked to imagine repetitive movement of the left index finger to the left thumb for 5 minutes. Subjects then will be asked to imagine sequential movement of left finger to left thumb (thumb to 2nd, 3rd, 4th, 5th) for 5 minutes.
Mental Imagery (MI) - Control Group Control Group - Mental Imagery: Subjects will be asked to perform simple mental math calculations for 20 minutes. (ex. adding or subtracting a one digit number from a starting number (1+1=2; 2+1=3; 3+1= 4 and so on.)
tDCS - Active This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS).
tDCS - Sham This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS).

Participant Flow:   Overall Study
    Motor Learning - MLsighted/MLblind/MLcontrol   Motor Learning (ML) MLblind/MLcontrol/MLsighted   Motor Learning (ML) MLcontrol Group/MLsighted/MLblind   Somatosensory Learning (SL Sighted)   Somatosensory Learning (SL Blind)   Somatosensory Activation (S Activation)   Somatosensory Learning (SL) Control Group   Observational Task (OT)   Observational Task (OT) - Control Group   Mental Imagery (MI)   Mental Imagery (MI) - Control Group   tDCS - Active   tDCS - Sham
STARTED   5   5   5   10   10   10   10   15   15   15   15   0   0 
COMPLETED   4   5   5   10   10   10   10   15   15   14   14   0   0 
NOT COMPLETED   1   0   0   0   0   0   0   0   0   1   1   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
Motor Learning (ML) This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
Somatosensory Learning (SL Sighted) No text entered.
Somatosensory Learning (SL Blind) No text entered.
Somatosensory Activation (S Activation) No text entered.
Somatosensory Learning (SL) Control Group No text entered.
Observational Task (OT) - Real No text entered.
Observational Task (OT) - Control No text entered.
Mental Imagery (MI) - Real No text entered.
Mental Imagery (MI) - Control No text entered.
Total Total of all reporting groups

Baseline Measures
   Motor Learning (ML)   Somatosensory Learning (SL Sighted)   Somatosensory Learning (SL Blind)   Somatosensory Activation (S Activation)   Somatosensory Learning (SL) Control Group   Observational Task (OT) - Real   Observational Task (OT) - Control   Mental Imagery (MI) - Real   Mental Imagery (MI) - Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   10   10   10   10   15   15   15   15   115 
Age 
[Units: Participants]
Count of Participants
                   
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      15 100.0%      10 100.0%      10 100.0%      10 100.0%      10 100.0%      15 100.0%      15 100.0%      15 100.0%      15 100.0%      115 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                   
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      15 100.0%      10 100.0%      10 100.0%      10 100.0%      10 100.0%      15 100.0%      15 100.0%      15 100.0%      15 100.0%      115 100.0% 


  Outcome Measures

1.  Primary:   Change in Motor Cortex Excitability MEP Amplitude   [ Time Frame: after each intervention ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Felipe Fregni
Organization: Spaulding Rehabilitation Hospital
phone: 6179526156
e-mail: felipe.fregni@ppcr.hms.harvard.edu



Responsible Party: Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01404039     History of Changes
Other Study ID Numbers: 2010-p-001256
Study First Received: June 29, 2011
Results First Received: April 7, 2015
Last Updated: March 14, 2017