Stroke Clinical Trial
Official title:
tDCS in Chronic Stroke Recovery-pilot
The hypothesis of this study is that different subgroups of stroke will respond differently to direct current stimulation.
We have tested the effectiveness of each stimulation condition: 1) anodal over the lesional
motor cortex 2) anodal PMD (positive electrode at the dorsal premotor cortex (PMD) of the
lesional hemisphere (first phase) or dual motor cortex stimulation (second phase), 3)
cathodal over the contralesional motor cortex, and 4) sham in a double blind crossover design
in chronic cortical and subcortical strokes.
Persons in the chronic stage of recovery from stroke (>3 months) will receive each type of
tDCS stimulation for 20 minutes concurrent with physical therapy treatments (90 minutes )
utilizing the Armeo ®, a gravity neutral arm exercise support system for the most involved
upper extremity which provides for task practice in a virtual reality environment, followed
by a therapist supervised targeted hand exercise. The experimental protocol will not alter
standard of care, will be performed after standard rehabilitation is completed. The
experimental therapy is not part of standard care and will not be charged or reimbursed by
the patients' insurance. Participation will be free of charge for subjects.
We were planning to perform the study in two phases. In the first exploratory phase, we will
conduct a short pilot study with 15 subjects to optimize and if possible simplify the
treatment parameters for the second longer phase of the experiment. In this first phase we
will perform one of the four different tDCS stimulation conditions concurrently with the
physical therapy protocol on each therapy day, so that all subjects will receive all
stimulation types in a randomized counterbalanced order. There will be a 1 day rest period in
between sessions, making 9 days (10 days if initial evaluation is done on the day before the
1st treatment) the total commitment time for the first phase of study.
The outcome measures were collected before and after each session. The outcome measures
collected after the 1 day rest provide the baseline for the next session will be also used as
to validate the stability of the treatment effect. Subjects participating in the first part
of the study will be offered the option to participate in the second longer phase of the
study. (please see table under study procedures)
In the second phase of the experiment we will perform only the promising stimulation
paradigms plus sham from the first part of the experiment in a random, counterbalanced order
on up to 30 chronic stroke subjects. If in the initial phase there are no differences found
between stimulation types in the cortical vs subcortical patient groups then all 3
stimulation paradigms will be performed in the second phase.
Based on our preliminary data, we will perform the following paradigms in the second phase:
1) sham 2) dual stimulation 3) optimized tDCS in a randomized counterbalanced order. The
optimized tDCS will be determined during a test session prior to the first treatment where
the tDCS montage producing the best behavioral response will be used during therapy. Subjects
will perform this under IRB approved study # STU 102013-085.
The patient time commitment in the second phase is 18 weeks, where subjects will have 3 x 1
weeks long treatment (5 weekdays) sessions with 5 week inter-treatment "rest period". The
blinded tester will perform a final outcome evaluation 5 weeks after the end of the last
session. (please see table under study procedures)
Total number of potential enrolled subjects for both phases will be approximately 45 [Phase 1
(15) + Phase 2 (30)].
The stepwise design will enable us to optimize study time commitment and expenses for both
patients and researchers while maximizing clinical/scientific gain.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Suspended |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Enrolling by invitation |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Active, not recruiting |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|