Transcranial Alternating Current Stimulation (tACS) to Improve Motor Skill Acquisition in Stroke Patients
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
TGP-tACS
Sham-tACS
Sponsored by

About this trial
This is an interventional basic science trial for Stroke focused on measuring Stroke, Hand motor impairment, Transcranial alternating current stimulation, Non-invasive brain stimulation, motor learning, sensorimotor cortex, crossfrequency coupling, theta-gamma phase amplitude coupling
Eligibility Criteria
Inclusion Criteria:
- German-speaking
- ability to perform a thumb movement task with the affected hand
- first-ever clinical ischemic stroke in the chronic phase
- persistent mild motor deficit of the upper extremity or motor deficit of the upper extremity in the acute phase over >24h
Exclusion Criteria:
- pronounced cognitive deficits
- history of major neurological or psychiatric illness other than stroke
- epilepsy or epileptic seizure in the history
- any devices or implants in the head region (e.g. cochlear implant, aneurysm clips),
- implanted pacemaker or medical pumps
- intake of psychotropic medication
- allergy to any ingredient of the local anesthetic cream
- pregnancy
Sites / Locations
- Department of Neurology, University Medical Center Hamburg-Eppendorf
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
TGP-tACS
Sham-tACS
Arm Description
Patients perform a motor skill acquisition task with the affected hand during TGP-stimulation over the sensorimotor cortex on the lesioned side.
Patients perform a motor skill acquisition task with the affected hand during sham-stimulation over the sensorimotor cortex on the lesioned side.
Outcomes
Primary Outcome Measures
Motor Skill Acquisition
Quotient of mean "Duration of Button Presses" of the best block and the baseline block. Best block is defined as the block with the lowest mean "Duration of Button Presses". "Duration of Button Press" is the Duration between the first and fourth button press of a valid trial.
Secondary Outcome Measures
Duration of Button Presses
Time span from first to last button press of a trial. Averaged for all trials of one block
Full Information
NCT ID
NCT05576129
First Posted
October 7, 2022
Last Updated
October 16, 2023
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Technical University of Twente, University of Oxford
1. Study Identification
Unique Protocol Identification Number
NCT05576129
Brief Title
Transcranial Alternating Current Stimulation (tACS) to Improve Motor Skill Acquisition in Stroke Patients
Official Title
Theta-gamma Transcranial Alternating Current Stimulation (tACS) to Modulate Activity in Sensorimotor Cortex for Improvement of Motor Skill Acquisition in Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
August 25, 2023 (Actual)
Study Completion Date
August 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Technical University of Twente, University of Oxford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hand motor function is often severely affected in stroke patients and its recovery is one primary goal in stroke rehabilitative treatment programs. Recently, theta-gamma transcranial alternating current stimulation (tACS) has been shown to enhance motor skill acquisition in healthy individuals. The aim of the present study is to examine the effect of theta-gamma tACS on motor skill acquisition in chronic stroke patients.
Detailed Description
Hand motor function is often severely affected in stroke patients and recovery of function is a primary goal in stroke rehabilitative treatment programs. Recently, theta-gamma tACS has been shown to enhance motor skill acquisition in healthy individuals [Akkad et al.2021]. The aim of the present study is to examine the effect of theta-gamma tACS on motor skill acquisition in chronic stroke patients.
In a randomized, controlled, triple-blind trial, chronic stroke patients with an initially impaired hand motor function will receive either (i) theta-gamma peak stimulation (TGP) or (ii) sham stimulation. TGP stimulation significantly improved motor learning in the study by Akkad et al (2021) compared to sham stimulation. tACS will be delivered through a five-electrode montage centered over the sensorimotor cortex on the lesioned side of the brain for approximately 38 min. During stimulation patients will perform a motor skill acquisition task performed with the affected hand. The task consists of short repetitive trials in which participants alternately press two buttons with their thumb. It is designed in a way that participants can improve their performance, more precisely the speed of button presses, and are encouraged to do so. To reduce skin sensations beneath the stimulation electrodes and thereby improve blinding compared to sham stimulation, a local anesthetic consisting of lidocaine and prilocaine will be administered underneath the stimulation electrodes.
Based on the results of the study by Akkad et al. (2021) and on the assumption that theta-gamma phase amplitude coupling is a key mechanism for motor skill acquisition, the investigators hypothesize that motor skill acquisition will differ significantly between the TGP and sham group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Hand motor impairment, Transcranial alternating current stimulation, Non-invasive brain stimulation, motor learning, sensorimotor cortex, crossfrequency coupling, theta-gamma phase amplitude coupling
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TGP-tACS
Arm Type
Active Comparator
Arm Description
Patients perform a motor skill acquisition task with the affected hand during TGP-stimulation over the sensorimotor cortex on the lesioned side.
Arm Title
Sham-tACS
Arm Type
Sham Comparator
Arm Description
Patients perform a motor skill acquisition task with the affected hand during sham-stimulation over the sensorimotor cortex on the lesioned side.
Intervention Type
Device
Intervention Name(s)
TGP-tACS
Intervention Description
38 min and 20s of 4mA peak-to-peak theta-gamma stimulation with 75 Hz-gamma coupled to the peak of 6Hz-theta waves. 3s ramp-up at the beginning of stimulation and 3s ramp-down at the end of stimulation.
Administered using a Starstim® device and 5 gel electrodes with a πcm² area.
Intervention Type
Device
Intervention Name(s)
Sham-tACS
Intervention Description
38 min and 20s of alternation between 10s of 4mA peak-to-peak TGP- tACS and a 6 min 30s stimulation-free interval. Each stimulation consists of 3s ramp-up, 4s TGP stimulation and 3s ramp-down. Administered using a Starstim® device and 5 gel electrodes with a πcm² area.
Primary Outcome Measure Information:
Title
Motor Skill Acquisition
Description
Quotient of mean "Duration of Button Presses" of the best block and the baseline block. Best block is defined as the block with the lowest mean "Duration of Button Presses". "Duration of Button Press" is the Duration between the first and fourth button press of a valid trial.
Time Frame
Over the course of the motor task with a duration of 38 minutes and 20 seconds.
Secondary Outcome Measure Information:
Title
Duration of Button Presses
Description
Time span from first to last button press of a trial. Averaged for all trials of one block
Time Frame
Baseline (consisting of 20 trials) and each of 6 blocks (consisting of 40 trials each)
Other Pre-specified Outcome Measures:
Title
"Thumb Speed" and "Thumb Acceleration"
Description
An accelerometer will be fixed to the medial distal phalanx of the thumb. It measures the thumb acceleration in all three dimensions of space. We will use the accelerometer data for post-hoc explorative analysis.
Time Frame
Over the course of the motor task with a duration of 38 minutes and 20 seconds.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
German-speaking
ability to perform a thumb movement task with the affected hand
first-ever clinical ischemic stroke in the chronic phase
persistent mild motor deficit of the upper extremity or motor deficit of the upper extremity in the acute phase over >24h
Exclusion Criteria:
pronounced cognitive deficits
history of major neurological or psychiatric illness other than stroke
epilepsy or epileptic seizure in the history
any devices or implants in the head region (e.g. cochlear implant, aneurysm clips),
implanted pacemaker or medical pumps
intake of psychotropic medication
allergy to any ingredient of the local anesthetic cream
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanny Quandt, Dr.
Organizational Affiliation
Department of Neurology; University Medical Center Hamburg-Eppendorf
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bettina Schwab, PhD
Organizational Affiliation
Biomedical Signals and Systems, Technical Medical Centre, University of Twente, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared after main publication of results
Citations:
PubMed Identifier
34812140
Citation
Akkad H, Dupont-Hadwen J, Kane E, Evans C, Barrett L, Frese A, Tetkovic I, Bestmann S, Stagg CJ. Increasing human motor skill acquisition by driving theta-gamma coupling. Elife. 2021 Nov 23;10:e67355. doi: 10.7554/eLife.67355.
Results Reference
background
Learn more about this trial
Transcranial Alternating Current Stimulation (tACS) to Improve Motor Skill Acquisition in Stroke Patients
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