Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function

Sponsor
Yun-Hee Kim (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05275114
Collaborator
Cybermedic Co., Ltd. (Other)
24
1
2
12
2

Study Details

Study Description

Brief Summary

The purpose of this study was to improve the effect of Transcranial Direct Current Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and hand motor function.

Condition or Disease Intervention/Treatment Phase
  • Device: tDCS stimulation with hand task
  • Device: sham tDCS stimulation with hand task
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hand Tasks + M1(1mA) & aIPS(1mA) tDCS

20 minutes of Hand Taks + applying 30 minutes of M1(1mA) & aIPS(1mA) tDCS and fNIRS

Device: tDCS stimulation with hand task
30 minutes of intervention including tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks

Active Comparator: Hand Tasks + Sham tDCS

20 minutes of Hand Tasks + 30 minutes of sham tDCS and fNIRS

Device: sham tDCS stimulation with hand task
30 minutes of intervention including sham tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks

Outcome Measures

Primary Outcome Measures

  1. Change in Fugl-Meyer Assessment [Session 0 (initial visit);; Session 10 (at approximatel 4 weeks)]

    The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.

Secondary Outcome Measures

  1. Change in 9-hole pegboard test [Baseline(initial visit); Session 10 (at approximatel 4 weeks)]

    The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.

  2. Change in Grip & Tip pinch strength [Baseline(initial visit); Session 10 (at approximatel 4 weeks)]

    The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.

  3. Change in Sequential finger tapping reaction time and accruacy [Baseline(initial visit); Session 10 (at approximatel 4 weeks)]

    Response time and accuracy are measured during finger tapping task.

  4. Change in Jebsen-Taylor hand function test [Baseline(initial visit); Session 10 (at approximatel 4 weeks)]

    This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).

  5. Change in Box and Block test [Baseline(initial visit); Session 10 (at approximatel 4 weeks)]

    The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.

  6. Changes in motor evoked potential [[Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]]

    Resting motor threshold (rMT) and amplitude of motor evoked potential in first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response.

  7. Changes in Brain activation of resting-state functional MRI [[Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]]

    Measure of Neuroplasticity

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients aged 19 to 80 years

  • Less than 58 FMA Upper scores

  • Patients whose lesions do not include stimulation regions

  • Patients with stroke with more than 3 months of onset

Exclusion Criteria:
  • Difficult to communicate due to severe language impairment.

  • Accompanied by an existing serious neurogenic disease

  • Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder

  • If there are difficulties in conducting the research

  • Any patients who are judged by the investigator to be difficult to participate in this study

  • Patients with contraindicated MRI scans

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 06351

Sponsors and Collaborators

  • Yun-Hee Kim
  • Cybermedic Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yun-Hee Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT05275114
Other Study ID Numbers:
  • 2021-06-176
First Posted:
Mar 11, 2022
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022