Stroke, Healthy
Conditions
Keywords
Stroke, Transcranial direct current stimulation, Motor function
Brief summary
The purpose of this study is to determine whether noninvasive brain stimulation associated with motor learning offers an additional benefit than motor learning alone in patients with stroke. The investigators hypothesis is that active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) will induce a greater motor function improvement as compared with sham tDCS combined with CIMT.
Detailed description
In this 3 experiments study we will evaluate the effect of tDCS and constraint induced movement therapy (CIMT) in stroke patients (exp 1) as well as in healthy subjects (control population - exp 2). Finally we will investigate the effect of tACS - transcranial alternating current stimulation - as an alternative to tDCS, on motor function in healthy subjects (exp 3). The two experiments on tDCS are parallels (exp 1 & 2), while the experiment on tACS uses a crossover design (exp 3). For stroke patients (Exp1), our primary outcome measure is a clinical scale (Jebsen-Taylor Hand Function Test), while for healthy subjects (Exp 2) we investigate the effect of tDCS and CIMIT on cortico-spinal excitability using TMS - transcranial magnetic stimulation. Finally, for the third experiment using tACS, our primary outcome is cortical oscillation, as measured by EEG - electroencephalogram.
Interventions
DEVICEtranscranial direct current stimulation (tDCS)
Subjects will be stimulated at 1 mA for 40 minutes.
DEVICEtranscranial alternating current stimulation (tACS)
Subjects will be stimulated at 15Hz for 20 minutes.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects must be between the ages of 18-90 and must not be pregnant. Additional Entry criteria for Stroke subject enrollment: 1. First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report; 2. Weakness, defined as score of less than 55 (out of 66) on arm motor Fugl-Meyer (FM) scale 3. Stroke onset \>6 months prior to study enrollment.
Exclusion criteria
1. Significant pre-stroke disability; 2. Major depression, as defined by Hamilton Depression (HAM-D) scale grater then or equal 17 if needed (history of depression before the stroke); 3. Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing; 4. Excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects); 5. Contraindications to single pulse Transcranial Magnetic Stimulation (TMS) (TMS will be used to measure cortical excitability) such as metal head implants * history of seizures * unexplained loss of consciousness * metal in the head * frequent or severe headaches or neck pain * implanted brain medical devices. 6. Contraindications to tDCS * metal in the head * implanted brain medical devices 7. Advanced liver, kidney, cardiac, or pulmonary disease; 8. A terminal medical diagnosis consistent with survival \< 1 year; 9. Coexistent major neurological or psychiatric disease as to decrease number of confounders; 10. A history of significant alcohol or drug abuse in the prior 6 months; 11. Use of carbamazepine and amitriptyline; 12. Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and 13. Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke; 14. History of epilepsy before stroke (or episodes of seizures within the last six months). 15. Subjects with global aphasia and deficits of comprehension 16. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Jebsen Taylor Hand Function Test | 2 weeks | Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-cronstrained hand for the assessments. The sum of the different tasks was used for the analysis. |
| Cortical Excitability | 1 hour | Motor evoked potential (MEP) Using Transcranial Magnetic Stimulation (TMS), MEP were recorded before and after tDCS (both active and sham). The percentage of change in MEP (post versus pre intervention) between the two groups (active and sham) were used for the comparison. |
| Cortical Oscillations - EEG | 15 minutes | Recording took place in a dim-lighted room set up with acoustic and electric isolation. EEG was acquired from 64-channels HydroCel Geodesic Sensor Net (Electrical Geodesic Inc., Eugene, OH) and recorded using Net Station running on a MacIntosh G4 computer. Alpha power were used as the main outcome measure. The difference values (e.g., post minus pre tACS) were used for the analysis. The alpha frequency is a brain oscillation that takes place especially when subjects are in a relaxed state, especially eyes closed. In the motor cortex, a decrease in alpha power has been seen during motor performance. Therefore, it could be speculated that a decrease in power in this study would indicate more engagement in motor cortex during the motor performance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| tDCS + CIMT - Stroke Participants received active tDCS over the primary motor cortex (M1). We used the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).
Transcranial Stimulation: Subjects were stimulated at 1 mA for 40 minutes. | 7 |
| Sham tDCS + CIMT - Stroke Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS. | 7 |
| tDCS Active + CIMT - Healthy Participants received active (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint. | 10 |
| Sham tDCS + CIMT - Healthy Participants received sham tDCS (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint. | 10 |
| tACS Active&Sham - Healthy active or sham 15Hz-tACS over of the primary motor cortex (M1) bilaterally. | 10 |
| Total | 44 |
Baseline characteristics
| Characteristic | tDCS + CIMT - Stroke | Sham tDCS + CIMT - Stroke | tDCS Active + CIMT - Healthy | Sham tDCS + CIMT - Healthy | tACS Active&Sham - Healthy | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 10 Participants | 10 Participants | 10 Participants | 43 Participants |
| Age, Continuous | 42.5 years STANDARD_DEVIATION 12.8 | 50.8 years STANDARD_DEVIATION 14.9 | 20.4 years STANDARD_DEVIATION 1.7 | 20.4 years STANDARD_DEVIATION 1.7 | 35.83 years STANDARD_DEVIATION 18.65 | 35.75 years STANDARD_DEVIATION 11.69 |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 7 Participants | 7 Participants | 4 Participants | 27 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 3 Participants | 3 Participants | 6 Participants | 17 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Cortical Excitability
Motor evoked potential (MEP) Using Transcranial Magnetic Stimulation (TMS), MEP were recorded before and after tDCS (both active and sham). The percentage of change in MEP (post versus pre intervention) between the two groups (active and sham) were used for the comparison.
Time frame: 1 hour
Population: The cortical excitability measurement (MEP) was performed in healthy participants involved in the tDCS+CIMT study (Experiment 2).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS + CIMT | Cortical Excitability | 19.8 percent change | Standard Deviation 21.4 |
| Sham tDCS + CIMT | Cortical Excitability | 0.8 percent change | Standard Deviation 8.3 |
Primary
Cortical Oscillations - EEG
Recording took place in a dim-lighted room set up with acoustic and electric isolation. EEG was acquired from 64-channels HydroCel Geodesic Sensor Net (Electrical Geodesic Inc., Eugene, OH) and recorded using Net Station running on a MacIntosh G4 computer. Alpha power were used as the main outcome measure. The difference values (e.g., post minus pre tACS) were used for the analysis. The alpha frequency is a brain oscillation that takes place especially when subjects are in a relaxed state, especially eyes closed. In the motor cortex, a decrease in alpha power has been seen during motor performance. Therefore, it could be speculated that a decrease in power in this study would indicate more engagement in motor cortex during the motor performance.
Time frame: 15 minutes
Population: The brain oscillations measurements were only performed in the tACS study (Experiment 3).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS + CIMT | Cortical Oscillations - EEG | -0.03 microVolt^2 | Standard Deviation 0.24 |
| Sham tDCS + CIMT | Cortical Oscillations - EEG | 0.07 microVolt^2 | Standard Deviation 0.16 |
Primary
Jebsen Taylor Hand Function Test
Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-cronstrained hand for the assessments. The sum of the different tasks was used for the analysis.
Time frame: 2 weeks
Population: The Jebsen Taylor Hand Function Test was only performed in the stroke study (Experiment 1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS + CIMT | Jebsen Taylor Hand Function Test | 68 seconds | Standard Error 34 |
| Sham tDCS + CIMT | Jebsen Taylor Hand Function Test | 80 seconds | Standard Error 42 |