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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
June 29, 2011
March 14, 2017
September 2010
April 2014   (Final data collection date for primary outcome measure)
Change in Motor Cortex Excitability MEP Amplitude [ Time Frame: after each intervention ]

We aim to assess the effects of the intervention (ML, SL, OT and MI) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after the given intervention.

  • For ML: MEP will be measured before and after each ML sessions in the same subject (crossover design - ML sighted/MLblind/ML control).
  • For SL: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group).
  • For OT: MEP will be measured before and after the treatment session in the each groups (parallel - 1 session per group).
  • For MI: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group).
Change in motor cortex excitability [ Time Frame: Varies per arm -- see description ]

We aim to assess the effects of the intervention (ML, SL, OT, MI and tDCS) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after the given intervention.

  • For ML: MEP will be measured over 3 visits (approximately 1 week).
  • For SL: MEP will be measured in one day only.
  • For OT: MEP will be measured in one day only.
  • For MI: MEP will be measured in one day only.
  • For tDCS Stimulation: MEP will be measured over two visits (approximately 1 week).
Complete list of historical versions of study NCT01404039 on ClinicalTrials.gov Archive Site
Not Provided
Change in mechanical pain threshold [ Time Frame: Varies per arm -- see description ]

We aim to assess the effects of the intervention (ML, SL, OT, MI and tDCS) on pain threshold as measured by pressure (in pounds) before and after the intervention.

  • For ML: Pain threshold will be measured over 3 visits (approximately 1 week).
  • For SL: Pain threshold will be measured in one day only.
  • For OT: Pain threshold will be measured in one day only.
  • For MI: Pain threshold will be measured in one day only.
  • For tDCS Stimulation: Pain threshold will be measured over two visits (approximately 1 week).
Not Provided
Not Provided
 
Investigating Motor Cortex Processing for Pain Modulation
Investigating Motor Cortex Processing for Pain Modulation
The purpose of this study is to investigate the effects of different types of interventions (motor learning, somatosensory learning, observation task, mental imagery and tDCS) on the perception of pain and motor cortex excitability in healthy male subjects. This is an exploratory study of healthy subjects only.

There are 5 experiments:

Exp1: motor learning (3 groups, crossover) - motor leaning with and without visual feedback and a control group.

Exp2: sensory learning (4 groups, parallel) - sensory learning with and without feedback, an simple activation task and a control group.

Exp3: observational task (2 groups, parallel) - an motor observational task and a control group.

Exp4: mental imagery (2 groups, parallel) - a motor mental imagery and a control group.

Exp5: tDCS over the motor cortex (2 groups, crossover) - active and sham tDCS. Note that this study has never been completed.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
There are 5 experiments: motor learning (3 groups, crossover), sensory learning (4 groups, parallel), observational task (2 groups, parallel), mental imagery (2 groups, parallel), and tDCS over the motor cortex (2 groups, crossover). Please note that the tDCS experiment has never been conducted.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Motor Activity
  • Behavioral: Motor Learning
    Subject will have to draw a set of shapes and words during 20 minutes.
  • Behavioral: Somatosensory Learning
    Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille.
  • Behavioral: Observational Task
    Subjects will watch a 10 second video of a right-handed person performing movements of their left index finger. Subjects will be instructed to watch the video without any other specific instruction.
  • Behavioral: Mental Imagery
    Subjects will be asked to perform mental imagery of motor practice - finger movements of the left hand for 10 minutes.
  • Device: transcranial direct current stimulation
    Subjects will undergo active and sham tDCS stimulation in a randomized and counterbalanced order. During both active and sham stimulation, we will use electrodes of 35cm^2, intensity of 2mA for a duration of 20 minutes. The anode electrode will be placed over the right primary motor cortex (M1) and the cathode will be placed over the contralateral supraorbital area. For active stimulation, the current will be on for the duration of 20 minutes. For sham stimulation, the current will ramp up, and then down again for 30 seconds to simulate the sensation of active tDCS.
  • Experimental: Motor Learning (ML) sighted

    In this arm, subject will perform motor Learning with visual feedback - ML sighted.

    There will be an anticipated total of 15 subjects in this experimental arm. 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.

    Intervention: Behavioral: Motor Learning
  • Experimental: Motor Learning (ML) blind

    In this arm, subject will perform motor Learning without visual feedback - ML blind.

    There will be an anticipated total of 15 subjects in this experimental arm. 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.

    Intervention: Behavioral: Motor Learning
  • Placebo Comparator: Motor Learning (ML) control group
    In this arm, subject will perform simple hand movements - control group. There will be an anticipated total of 15 subjects in this experimental arm. 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.
    Intervention: Behavioral: Motor Learning
  • Experimental: 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).

    Intervention: Behavioral: Somatosensory Learning
  • Experimental: 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).

    Intervention: Behavioral: Somatosensory Learning
  • Experimental: 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).

    Intervention: Behavioral: Somatosensory Learning
  • Placebo Comparator: 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).

    Intervention: Behavioral: Somatosensory Learning
  • Experimental: Observational Task (OT) - real
    In this arm, the subjects will perform an observational task - observation of hand movements. This experimental arm will be conducted in a parallel design. There will be 15 subjects per intervention.
    Intervention: Behavioral: Observational Task
  • Placebo Comparator: Observational Task (OT) - control group
    In this arm, the subjects will perform a controlled observational task - observation of geometric shapes. This experimental arm will be conducted in a parallel design. There will be 15 subjects per intervention.
    Intervention: Behavioral: Observational Task
  • Experimental: Mental Imagery (MI) - real
    In this arm, the subjects will perform mental imagery - mental imagery of finger movements. This experimental arm will be conducted in a parallel design. There will be 15 subjects per intervention.
    Intervention: Behavioral: Mental Imagery
  • Placebo Comparator: Mental Imagery (MI) - control group
    In this arm, the subjects will perform a controlled task - simple mental calculation. This experimental arm will be conducted in a parallel design. There will be 15 subjects per intervention.
    Intervention: Behavioral: Mental Imagery
  • Experimental: transcranial direct current stimulation - tDCS real
    tDCS will be applied over the motor cortex for 20minutes at an intensity of 2mA. 15 subjects will be enrolled. The subjects will undergo two interventions, real and sham in a counterbalanced randomized order. There will be at least 3 days between each experimental session.
    Intervention: Device: transcranial direct current stimulation
  • Placebo Comparator: transcranial direct current stimulation - tDCS sham

    tDCS will be applied over the motor cortex for 20minutes at an intensity of 2mA. The stimulation will be stopped after 30seconds.

    15 subjects will be enrolled. The subjects will undergo two interventions, real and sham in a counterbalanced randomized order. There will be at least 3 days between each experimental session.

    Intervention: Device: transcranial direct current stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
115
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. Provide informed consent to participate in the study
  2. 18 to 64 years old
  3. No presence of rheumatologic disease as self reported
  4. No clinically significant or unstable medical or psychiatric disorder as self reported
  5. No history of alcohol or substance abuse within the last 6 months as self reported
  6. No neuropsychiatric co-morbidity as self reported
  7. No Contraindications to single pulse TMS (TMS will be used to measure cortical excitability)

    • history of seizures
    • unexplained loss of consciousness
    • metal in the head
    • frequent or severe headaches or neck pain
    • implanted brain medical devices
  8. No Contraindications to tDCS

    • metal in the head
    • implanted brain medical devices
Sexes Eligible for Study: Male
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01404039
2010-p-001256
No
Not Provided
Not Provided
Felipe Fregni, Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
Not Provided
Principal Investigator: Felipe Fregni, MD, PhD, MPH Spaulding Rehabilitation Hospital (SRH)
Spaulding Rehabilitation Hospital
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP