Transcranial Alternating Current Stimulation (tACS) to Improve Motor Skill Acquisition in Stroke Patients
NCT ID: NCT05576129
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-11-14
2023-08-25
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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TGP-tACS
Patients perform a motor skill acquisition task with the affected hand during TGP-stimulation over the sensorimotor cortex on the lesioned side.
TGP-tACS
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.
Sham-tACS
Patients perform a motor skill acquisition task with the affected hand during sham-stimulation over the sensorimotor cortex on the lesioned side.
Sham-tACS
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.
Interventions
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TGP-tACS
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.
Sham-tACS
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Technical University of Twente
OTHER
University of Oxford
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Fanny Quandt
Principal Investigator
Principal Investigators
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Fanny Quandt, Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology; University Medical Center Hamburg-Eppendorf
Bettina Schwab, PhD
Role: PRINCIPAL_INVESTIGATOR
Biomedical Signals and Systems, Technical Medical Centre, University of Twente, The Netherlands
Locations
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Department of Neurology, University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Countries
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References
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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.
Grigutsch LS, Haverland B, Timmsen LS, Asmussen L, Braass H, Wolf S, Luu TV, Stagg CJ, Schulz R, Quandt F, Schwab BC. Differential effects of theta-gamma tACS on motor skill acquisition in young individuals and stroke survivors: A double-blind, randomized, sham-controlled study. Brain Stimul. 2024 Sep-Oct;17(5):1076-1085. doi: 10.1016/j.brs.2024.09.001. Epub 2024 Sep 6.
Other Identifiers
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CFC_tACS_Stroke
Identifier Type: -
Identifier Source: org_study_id