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Study was halted due to lack of funding.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motor Learning (ML) sighted | Experimental | 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. |
|
| Motor Learning (ML) blind | Experimental | 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. |
|
| Motor Learning (ML) control group | Placebo Comparator | 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. |
|
| Somatosensory Learning (SL sighted) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor Learning | Behavioral | Subject will have to draw a set of shapes and words during 20 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| after each intervention |
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Inclusion Criteria
Provide informed consent to participate in the study
18 to 64 years old
No presence of rheumatologic disease as self reported
No clinically significant or unstable medical or psychiatric disorder as self reported
No history of alcohol or substance abuse within the last 6 months as self reported
No neuropsychiatric co-morbidity as self reported
No Contraindications to single pulse TMS (TMS will be used to measure cortical excitability)
No Contraindications to tDCS
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Fregni, MD, PhD, MPH | Spaulding Rehabilitation Hospital (SRH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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). |
| FG004 | 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). |
| FG005 | 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). |
| FG006 | 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). |
| FG007 | 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. |
| FG008 | 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. |
| FG009 | 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. |
| FG010 | 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.) |
| FG011 | tDCS - Active | This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS). |
| FG012 | tDCS - Sham | This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.
| 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. | Posted | Mean | Standard Deviation | microV | after each intervention |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motor Learning (ML) Sighted |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Felipe Fregni | Spaulding Rehabilitation Hospital | 6179526156 | felipe.fregni@ppcr.hms.harvard.edu |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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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.
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| Experimental |
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) | Experimental | 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) | Experimental | 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 | Placebo Comparator | 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) - real | Experimental | 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. |
|
| Observational Task (OT) - control group | Placebo Comparator | 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. |
|
| Mental Imagery (MI) - real | Experimental | 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. |
|
| Mental Imagery (MI) - control group | Placebo Comparator | 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. |
|
| transcranial direct current stimulation - tDCS real | Experimental | 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. |
|
| transcranial direct current stimulation - tDCS sham | Placebo Comparator | 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. |
|
| Somatosensory Learning | Behavioral | Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille. |
|
| Observational Task | Behavioral | 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. |
|
| Mental Imagery | Behavioral | Subjects will be asked to perform mental imagery of motor practice - finger movements of the left hand for 10 minutes. |
|
| transcranial direct current stimulation | Device | 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. |
|
| Somatosensory Learning (SL Sighted) |
| BG002 | Somatosensory Learning (SL Blind) |
| BG003 | Somatosensory Activation (S Activation) |
| BG004 | Somatosensory Learning (SL) Control Group |
| BG005 | Observational Task (OT) - Real |
| BG006 | Observational Task (OT) - Control |
| BG007 | Mental Imagery (MI) - Real |
| BG008 | Mental Imagery (MI) - Control |
| BG009 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Motor Learning (ML)-Sighted | |
| OG001 | Motor Learning -ML Blind | |
| OG002 | Motor Learning - ML Control | |
| OG003 | Somatosensory Learning (SL)- SL Sighted | |
| OG004 | Somatosensory Learning (SL)-SL Blind | |
| OG005 | Somatosensory Learning (SL)-SL Activation | |
| OG006 | Somatosensory Learning (SL)-SL Control | |
| OG007 | Observational Task (OT)- OT Real | |
| OG008 | Observational Task (OT)- OT Control | |
| OG009 | Mental Imagery (MI) - MI Real | |
| OG010 | Mental Imagery (MI) - MI Control |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Motor Learning (ML) Blind | 0 | 15 | 0 | 15 |
| EG002 | Motor Learning (ML) Control | 0 | 15 | 0 | 15 |
| EG003 | Somatosensory Learning (SL) Sighted | 0 | 10 | 0 | 10 |
| EG004 | Somatosensory Learning (SL) Blind | 0 | 10 | 0 | 10 |
| EG005 | Somatosensory Activation (SA) | 0 | 10 | 0 | 10 |
| EG006 | Somatosensory Learning (SL) Control | 0 | 10 | 0 | 10 |
| EG007 | Observational Task (OT) - Real | 0 | 15 | 0 | 15 |
| EG008 | Observational Task (OT) - Control | 0 | 15 | 0 | 15 |
| EG009 | Mental Imagery (MI) - Real | 0 | 15 | 0 | 15 |
| EG010 | Mental Imagery (MI) - Control | 0 | 15 | 0 | 15 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |