This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
  Purpose
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.

Condition Intervention Phase
Motor Activity Behavioral: Motor Learning Behavioral: Somatosensory Learning Behavioral: Observational Task Behavioral: Mental Imagery Device: transcranial direct current stimulation Phase 1

Study Type: Interventional
Study Design: 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
Official Title: Investigating Motor Cortex Processing for Pain Modulation

Further study details as provided by Felipe Fregni, Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • 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).


Enrollment: 115
Study Start Date: September 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Behavioral: Motor Learning
Subject will have to draw a set of shapes and words during 20 minutes.
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.

Behavioral: Motor Learning
Subject will have to draw a set of shapes and words during 20 minutes.
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.
Behavioral: Motor Learning
Subject will have to draw a set of shapes and words during 20 minutes.
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).

Behavioral: Somatosensory Learning
Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille.
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).

Behavioral: Somatosensory Learning
Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille.
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).

Behavioral: Somatosensory Learning
Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille.
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).

Behavioral: Somatosensory Learning
Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille.
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.
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.
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.
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.
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.
Behavioral: Mental Imagery
Subjects will be asked to perform mental imagery of motor practice - finger movements of the left hand for 10 minutes.
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.
Behavioral: Mental Imagery
Subjects will be asked to perform mental imagery of motor practice - finger movements of the left hand for 10 minutes.
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.
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.
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.

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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404039

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, MD, PhD, MPH Spaulding Rehabilitation Hospital (SRH)
  More Information

Responsible Party: Felipe Fregni, Principal Investigator, 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

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
learning
pain perception

Additional relevant MeSH terms:
Menthol
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on August 17, 2017