Motor Activity
Conditions
Keywords
learning, pain perception
Brief summary
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.
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.
Interventions
BEHAVIORALMotor Learning
Subject will have to draw a set of shapes and words during 20 minutes.
BEHAVIORALSomatosensory Learning
Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille.
BEHAVIORALObservational 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.
BEHAVIORALMental Imagery
Subjects will be asked to perform mental imagery of motor practice - finger movements of the left hand for 10 minutes.
DEVICEtranscranial 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.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor Cortex Excitability MEP Amplitude | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Somatosensory Learning (SL Sighted) | 10 |
| Somatosensory Learning (SL Blind) | 10 |
| Somatosensory Activation (S Activation) | 10 |
| Somatosensory Learning (SL) Control Group | 10 |
| Observational Task (OT) - Real | 15 |
| Observational Task (OT) - Control | 15 |
| Mental Imagery (MI) - Real | 15 |
| Mental Imagery (MI) - Control | 15 |
| Total | 115 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 115 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 15 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in Motor Cortex Excitability MEP Amplitude
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).
Time frame: after each intervention
Population: ML: crossover design - ML sighted/MLblind/ML control. 15 patients were enrolled, but one participant dropped-out after the first intervention - participants with available data: 14.~SL: parallel design - SL sighted/SLblind/Sactivation/SLcontrol. OT: parallel design - OT real and OT control. MI: parallel design - MI real and MI control.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motor Learning (ML)-Sighted | Change in Motor Cortex Excitability MEP Amplitude | After | 1.27 microV | Standard Deviation 0.35 |
| Motor Learning (ML)-Sighted | Change in Motor Cortex Excitability MEP Amplitude | Before | 1.37 microV | Standard Deviation 0.32 |
| Motor Learning -ML Blind | Change in Motor Cortex Excitability MEP Amplitude | After | 1.4 microV | Standard Deviation 0.28 |
| Motor Learning -ML Blind | Change in Motor Cortex Excitability MEP Amplitude | Before | 1.39 microV | Standard Deviation 0.25 |
| Motor Learning - ML Control | Change in Motor Cortex Excitability MEP Amplitude | Before | 1.28 microV | Standard Deviation 0.23 |
| Motor Learning - ML Control | Change in Motor Cortex Excitability MEP Amplitude | After | 1.49 microV | Standard Deviation 0.35 |
| Somatosensory Learning (SL)- SL Sighted | Change in Motor Cortex Excitability MEP Amplitude | After | 1.59 microV | Standard Deviation 0.73 |
| Somatosensory Learning (SL)- SL Sighted | Change in Motor Cortex Excitability MEP Amplitude | Before | 1.74 microV | Standard Deviation 0.78 |
| Somatosensory Learning (SL)-SL Blind | Change in Motor Cortex Excitability MEP Amplitude | After | 1.47 microV | Standard Deviation 0.5 |
| Somatosensory Learning (SL)-SL Blind | Change in Motor Cortex Excitability MEP Amplitude | Before | 1.67 microV | Standard Deviation 0.5 |
| Somatosensory Learning (SL)-SL Activation | Change in Motor Cortex Excitability MEP Amplitude | Before | 1.32 microV | Standard Deviation 0.29 |
| Somatosensory Learning (SL)-SL Activation | Change in Motor Cortex Excitability MEP Amplitude | After | 1.18 microV | Standard Deviation 0.39 |
| Somatosensory Learning (SL)-SL Control | Change in Motor Cortex Excitability MEP Amplitude | Before | 1.30 microV | Standard Deviation 0.39 |
| Somatosensory Learning (SL)-SL Control | Change in Motor Cortex Excitability MEP Amplitude | After | 1.28 microV | Standard Deviation 0.44 |
| Observational Task (OT)- OT Real | Change in Motor Cortex Excitability MEP Amplitude | Before | 1.93 microV | Standard Deviation 0.75 |
| Observational Task (OT)- OT Real | Change in Motor Cortex Excitability MEP Amplitude | After | 1.83 microV | Standard Deviation 0.74 |
| Observational Task (OT)- OT Control | Change in Motor Cortex Excitability MEP Amplitude | After | 1.65 microV | Standard Deviation 0.75 |
| Observational Task (OT)- OT Control | Change in Motor Cortex Excitability MEP Amplitude | Before | 1.79 microV | Standard Deviation 0.78 |
| Mental Imagery (MI) - MI Real | Change in Motor Cortex Excitability MEP Amplitude | After | 1.41 microV | Standard Deviation 0.81 |
| Mental Imagery (MI) - MI Real | Change in Motor Cortex Excitability MEP Amplitude | Before | 1.49 microV | Standard Deviation 0.81 |
| Mental Imagery (MI) - MI Control | Change in Motor Cortex Excitability MEP Amplitude | After | 1.66 microV | Standard Deviation 1.01 |
| Mental Imagery (MI) - MI Control | Change in Motor Cortex Excitability MEP Amplitude | Before | 1.70 microV | Standard Deviation 1.12 |