Transcranial Alternating Current Stimulation (tACS) to Improve Motor Skill Acquisition in Stroke Patients

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT05576129
Collaborator
Technical University of Twente (Other), University of Oxford (Other)
20
1
2
12.6
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TGP-tACS
  • Device: Sham-tACS
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Theta-gamma Transcranial Alternating Current Stimulation (tACS) to Modulate Activity in Sensorimotor Cortex for Improvement of Motor Skill Acquisition in Stroke Patients
Actual Study Start Date :
Nov 14, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: TGP-tACS

Patients perform a motor skill acquisition task with the affected hand during TGP-stimulation over the sensorimotor cortex on the lesioned side.

Device: 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 Comparator: Sham-tACS

Patients perform a motor skill acquisition task with the affected hand during sham-stimulation over the sensorimotor cortex on the lesioned side.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Motor Skill Acquisition [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.

Secondary Outcome Measures

  1. Duration of Button Presses [Baseline (consisting of 20 trials) and each of 6 blocks (consisting of 40 trials each)]

    Time span from first to last button press of a trial. Averaged for all trials of one block

Other Outcome Measures

  1. "Thumb Speed" and "Thumb Acceleration" [Over the course of the motor task with a duration of 38 minutes and 20 seconds.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Neurology, University Medical Center Hamburg-Eppendorf Hamburg Germany 20246

Sponsors and Collaborators

  • Universitätsklinikum Hamburg-Eppendorf
  • Technical University of Twente
  • University of Oxford

Investigators

  • Principal Investigator: Fanny Quandt, Dr., Department of Neurology; University Medical Center Hamburg-Eppendorf
  • Principal Investigator: Bettina Schwab, PhD, Biomedical Signals and Systems, Technical Medical Centre, University of Twente, The Netherlands

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fanny Quandt, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT05576129
Other Study ID Numbers:
  • CFC_tACS_Stroke
First Posted:
Oct 12, 2022
Last Update Posted:
Nov 15, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fanny Quandt, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2022