StrokeNCT05576129
Transcranial Alternating Current Stimulation (tACS) to Improve Motor Skill Acquisition in Stroke Patients
A study testing TGP-tACS in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- TGP-tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 14 Nov 2022to 25 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: Theta-gamma Transcranial Alternating Current Stimulation (tACS) to Modulate Activity in Sensorimotor Cortex for Improvement of Motor Skill Acquisition in Stroke Patients
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- TGP-tACS, Sham-tACS
- Keywords
- Stroke, Hand motor impairment, Transcranial alternating current stimulation, Non-invasive brain stimulation, motor learning, sensorimotor cortex, crossfrequency coupling, theta-gamma phase amplitude coupling
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGP-tACSDevice
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-tACSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TGP-tACS | Active comparator | Patients perform a motor skill acquisition task with the affected hand during TGP-stimulation over the sensorimotor cortex on the lesioned side. Receives: Device: TGP-tACS |
| Sham-tACS | Sham comparator | Patients perform a motor skill acquisition task with the affected hand during sham-stimulation over the sensorimotor cortex on the lesioned side. Receives: Device: Sham-tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over the course of the motor task with a duration of 38 minutes and 20 seconds.
Secondary outcomes (1)
Duration of Button Presses
Time span from first to last button press of a trial. Averaged for all trials of one block
Measured: Baseline (consisting of 20 trials) and each of 6 blocks (consisting of 40 trials each)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start14 Nov 2022
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Twente, University of Oxford
- Responsible party
- Principal investigator, Fanny Quandt, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Fanny Quandt, Dr., Principal investigator, Department of Neurology; University Medical Center Hamburg-EppendorfBettina Schwab, PhD, Principal investigator, Biomedical Signals and Systems, Technical Medical Centre, University of Twente, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576129
- Sponsor's protocol ID
- CFC_tACS_Stroke
- Status last verified
- Dec 2024
- First submitted
- 7 Oct 2022
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after main publication of results
Publications
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.
PubMed 34812140Grigutsch 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.
PubMed 39245294
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta-gamma Transcranial Alternating Current Stimulation (tACS) to Modulate Activity in Sensorimotor Cortex for Improvement of Motor Skill Acquisition in Stroke Patients
- ClinicalTrials.gov ID
- NCT05576129
- Acronym / sponsor ID
- CFC_tACS_Stroke
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Technical University of Twente, University of Oxford
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TGP-tACS | Active comparator | Device: TGP-tACSPatients perform a motor skill acquisition task with the affected hand during TGP-stimulation over the sensorimotor cortex on the lesioned side. |
| Sham-tACS | Sham comparator | Device: Sham-tACSPatients perform a motor skill acquisition task with the affected hand during sham-stimulation over the sensorimotor cortex on the lesioned side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGP-tACS38 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. | Device | TGP-tACS |
| Sham-tACS38 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. | Device | Sham-tACS |
Primary outcome
Motor Skill Acquisition
Time frame: Over the course of the motor task with a duration of 38 minutes and 20 seconds.
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.
1 secondary outcome
Duration of Button Presses
Time frame: Baseline (consisting of 20 trials) and each of 6 blocks (consisting of 40 trials each)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Background: PubMed 34812140Akkad 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 publication: PubMed 39245294Grigutsch 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.
- Individual participant dataSharing planned: Yes. Data will be shared after main publication of results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny Quandt, Dr. principal investigator
Department of Neurology; University Medical Center Hamburg-Eppendorf
Bettina Schwab, PhD principal investigator
Biomedical Signals and Systems, Technical Medical Centre, University of Twente, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TGP-tACS in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Skill Acquisition (time frame: Over the course of the motor task with a duration of 38 minutes and 20 seconds.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05576129, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.