Overview

This trial is active, not recruiting.

Condition motor activity
Treatments motor learning with visual feedback, motor learning without visual feedback, motor learning -- control group, somatosensory learning with visual feedback, somatosensory learning without visual feedback, control group - sensory task without learning, control group -- no sensory or learning task, observational task, control group -- observational task, mental imagery, control group - mental imagery, transcranial direct current stimulation
Phase phase 1
Sponsor Spaulding Rehabilitation Hospital
Start date September 2010
End date December 2014
Trial size 150 participants
Trial identifier NCT01404039, 2010-p-001256

Summary

The purpose of this study is to investigate the effects of different types of interventions (motor learning, somatosensory learning, mental imagery, observation, and tDCS) on the perception of pain and motor cortex excitability in healthy male subjects. This is an exploratory study of healthy subjects only.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
This arm will be conducted as a cross-over design. There will be an anticipated total of 15 subjects in this experimental arm. 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 with visual feedback
This task will consist of tracing a set of symbols using the index finger of the left hand. Subjects will do this task for 20 minutes. Subjects will repeat this activity until the end of that time. The speed will be measured using a timer, and accuracy will be measured using the computer program Image Java, NIH, USA.
motor learning without visual feedback
In this group, subjects will be asked to use the index finger of their left hand to draw a square while wearing a blindfold. The task will be performed with the subject sitting and arms supported. The square will have four pins, one at each corner, to give feedback of where they need to scroll. This task will be performed for a total of 20 minutes.
motor learning -- control group
In this group, subjects will perform the following sequences of movements: Pronation and supination of the forearm Flexion and extension of wrist Abduction and adduction of fingers Open and close hand movements These tasks will be performed for 20 minutes (5 minutes for each sequence) in a single session.
(Experimental)
In this arm, there will be 15 subjects per group and it will be conducted in a parallel manner. There will be an anticipated total of 60 subjects in this arm. Each subject will undergo only one of the four interventions in this arm (somatosensory learning with visual feedback, somatosensory learning without visual feedback, control group -- sensory task without learning, control group -- no sensory or learning task). The order of the interventions will be randomized.
somatosensory learning with visual feedback
Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille. The subject will be able to see the braille letters as he/she learns the letters.
somatosensory learning without visual feedback
Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille while blindfolded.
control group - sensory task without learning
This group will perform a task for sensory activation, without a learning task. Subjects will be instructed to put their hand on the desk with their palm facing up. During the 20 minute intervention period, the study staff will touch the subject's hand with items of different textures.
control group -- no sensory or learning task
This group will perform no task during the intervention period. The subject will sit quietly with their hand placed palm-up on a desk for the duration of the intervention period.
(Experimental)
This experimental arm will be conducted in a parallel design. There will be 15 subjects per intervention for an anticipated total of 30 subjects in this arm. Each subject will undergo one of the two interventions in this arm (observational task, or control group). The order of the interventions will be randomized.
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.
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.
(Experimental)
This experimental arm will be conducted in a parallel design. There will be 15 subjects per group for an estimated total of 30 subjects in this experimental arm. Each subject will undergo one of the two interventions (mental imagery or control group). The order of the interventions will be randomized.
mental imagery
Subjects will be seated in a chair and will be asked to keep their arm and hand muscles fully relaxed. They will then be asked to imagine repetitive movement of the left index finger to the left thumb for 5 minutes. Subjects will then be asked to imagine sequential movement of left finger to left thumb (thumb to 2nd, 3rd, 4th, 5th) for 5 minutes. Subjects will be asked to imagine sequential and repetitive finger movements of the left hand, for a duration of 10 minutes.
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.)
(Experimental)
This experimental arm will be conducted in a cross-over design. Fifteen subjects will undergo both interventions of this arm (active tDCS and sham tDCS) in a randomized and counterbalanced order. There will be at least 3 days between each intervention to prevent carryover effects.
transcranial direct current stimulation low intensity 1x1 direct current stimulator
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.

Primary Outcomes

Measure
Change in motor cortex excitability
time frame: Varies per arm -- see description

Secondary Outcomes

Measure
Change in mechanical pain threshold
time frame: Varies per arm -- see description

Eligibility Criteria

Male participants from 18 years up to 64 years old.

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

Additional Information

Official title Investigating Motor Cortex Processing for Pain Modulation
Principal investigator Felipe Fregni, MD, PhD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.