tACS for Sensory Motor Recovery After Stroke

Study Overview
=================
Brief Summary
-----------------
The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for motor recovery in stroke survivors.

Official Title
-----------------
tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments

Conditions
-----------------
Motor Recovery

Intervention / Treatment
-----------------
* Device: tACS Sham
* Device: tACS 10Hz
* Device: tACS 20Hz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion/exclusion criteria for stroke subjects Inclusion criteria: Age between 18 75 years old ≥ 6 months post stroke, medically stable; Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke); Visible finger flexor activation/movement The ability to give consent Exclusion criteria: Patients with visual deficit/neglect; hearing or cognitive impairment; Patients that are currently adjusting tone alternating medications (e.g., baclofen), or Patients received botulinum toxin injection to the arm/fingers <4 months, or phenol injections <2 years; Patients with pacemaker, metal implants or supplemental oxygen; Patients who have musculoskeletal disorders, including pain in the affected side Women who are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tACS Sham, tACS 10Hz, tACS 20Hz<br>tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns. | Device: tACS Sham<br>* Sham tACS will applied to the brain through the scalp for 20 minutes.<br>Device: tACS 10Hz<br>* 10Hz tACS will applied to the brain through the scalp for 20 minutes.<br>Device: tACS 20Hz<br>* 20Hz tACS will applied to the brain through the scalp for 20 minutes.<br>|
| Experimental: HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham<br>tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns. | Device: tACS Sham<br>* Sham tACS will applied to the brain through the scalp for 20 minutes.<br>Device: tACS 10Hz<br>* 10Hz tACS will applied to the brain through the scalp for 20 minutes.<br>Device: tACS 20Hz<br>* 20Hz tACS will applied to the brain through the scalp for 20 minutes.<br>|
| Experimental: HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham<br>tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns. | Device: tACS Sham<br>* Sham tACS will applied to the brain through the scalp for 20 minutes.<br>Device: tACS 10Hz<br>* 10Hz tACS will applied to the brain through the scalp for 20 minutes.<br>Device: tACS 20Hz<br>* 20Hz tACS will applied to the brain through the scalp for 20 minutes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block and Box Test (BBT) of Motor functional test | The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick and simple test used with a wide range of populations, including clients with stroke. | Change of BBT performance 5 minutes before and 5 minutes after the tACS intervention will be measured. | 
| EEG alpha band and Beta band | Electroencephalography (EEG) is valuable to infer and evaluate the neural interaction. Components of the alpha and beta frequency bands like the sensorimotor rhythm originated from the primary motor cortex and related brain areas reflect human movement. The power of 8-13 Hz alpha and 14-30 Hz beta frequency bands will be used for the classification. | Change of EEG alpha band and Beta band 5 minutes before and 5 minutes after the tACS intervention will be measured. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tACS, Motor recovery