|First Submitted Date||April 13, 2006|
|First Posted Date||April 14, 2006|
|Last Update Posted Date||July 2, 2017|
|Start Date||April 7, 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00314769 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Long-Term Improvement in Motor Learning by Transcranial Direct Current Stimulation|
|Official Title||Long-Term Improvement in Training Effects by Transcranial DC Stimulation|
This study will examine whether continuous use of transcranial direct current stimulation (tDCS) in combination with motor training can lead to long-term improvement in movement performance beyond what can be achieved with motor training alone.
Healthy normal volunteers 18-80 years of age who are clearly right- or left-handed may be eligible for this study. Each candidate is screened with a medical history, clinical and neurological examination, questionnaires to evaluate memory, attention, and handedness and a brain MRI, if one has not been done by NINDS within 12 months of entering the study. Pregnant women may not participate.
The study involves 10 sessions (in addition to the screening visit) over 3 months. Sessions 1-5 are completed over 5 consecutive days. Sessions 6-10 are divided over the remaining time. Participants are randomly assigned to one of three groups: 1) tDCS during motor training; 2) tDCS after training; or 3) training with sham tDCS. During these sessions, participants perform a pinch force task (squeezing a small device between the thumb and forefinger) and visuomotor tasks (using a device to move the cursor on a computer screen to various targets and holding the cursor in place for 1 second).
During the motor training and performance sessions, participants have the following procedures.
Motor practice and use over one session leads to use-dependent plasticity. When practice is repeated over multiple sessions, motor performance continues improving until a plateau in performance, the so-called ceiling effect is reached. This issue is particularly important in neurorehabilitative treatments in which patients usually reach a ceiling effect without further improvement. Thus, it would be desirable to modify ceiling effects in motor rehabilitation. The purpose of this protocol is to determine if repeated applications of TDCS, a form of non-invasive cortical stimulation known to transiently improve performance, in association with training, could elicit additional improvements in motor performance beyond the ceiling effect identified during performance of a visuomotor training task.
We will test the hypothesis that anodal TDCS applied over M1 in temporal relation with motor training will lead to more prominent long-term learning of a visuomotor task relative to sham stimulation (which would document the ceiling effect) in healthy individuals and chronic stroke patients and traumatic brain injury (TB1) patients..
We plan to study 177 healthy volunteers (part 1) and 60 chronic stroke patients (part 2) and 50 TB1 patients with 50 additional healthy volunteers (part 3). Therefore, an overall enrollment of 337 participants is planned.
The study will follow a parallel design. Healthy volunteers (part 1) and stroke patients (part 2)will be randomly allocated to one of three groups. Each group will receive anodal TDCS or sham in a fixed time frame related to motor training (during or immediately after motor training). TB1 patients and healthy volunteers (part 3) will be randomly allocated to one of two groups. Each group will receive either sham or anodal tDCS during training.
Healthy volunteers and stroke patients will participate in 10 sessions. First, they will train a visuomotor task (VMT) on 5 consecutive days while receiving sham stimulation (group 3) or TDCS during (group 1), or immediately after (group 2) the training. Performance of the VMT will be re-evaluated at 30, 60 and 90 days after the first training session.
Traumatic brain injury (TB1) patients and a group of healthy volunteers (part 3) will participate in 6 sessions. First, they will train a visumomotor task (VMT) on 3 consecutive days while receiving anodal tDCS or sham stimulation during the training. Performance of the VMT will be re-evaluated at 30, 60, and 90 days after the first training session.
Primary outcome measure will be the percentage change (from baseline to day 8 in healthy volunteers and stroke patients, and from baseline to day 3 in traumatic brain injury) in the total time necessary to complete 15 correct trials of the visuomotor task.
Secondary outcome will be accuracy (no. of errors) and timing (speed) variability of force adaptation in the visuomotor task (Celnik, own data), and pinch force at all other time points, including day 5 as a measure of learning over the training period and 3 months as a measure for long-term retention. In the patient group the Jebsen Taylor Test will be used to assess gross motor function. To better understand the mechanisms underlying the proposed behavioral gains, we will use single- and paired pulse transcranial magnetic stimulation (TMS) to identify corticomotor excitability changes. Furthermore the volunteers will answer several questionnaires to evaluate fatigue and mood (PANAS) and perform short neuropsychological control task to control for changes in attention and memory function.
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Estimated Completion Date||December 16, 2013|
|Primary Completion Date||Not Provided|
We will include HEALTHY VOLUNTEERS under the following circumstances:
We will include STROKE PATIENTS under the following circumstances:
We will include TBI PATIENTS under the following circumstances:
We will exclude healthy volunteers and stroke patients, and TBI patients if one of the following conditions applies:
|Ages||18 Years to 80 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||060138
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 16, 2013|