Back to results

The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory

Primary Purpose

Central Nervous System Diseases

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Functional near infrared spectroscopy

rTMS

About this trial

This is an interventional treatment trial for Central Nervous System Diseases

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ischemic or hemorrhagic cerebrovascular lesion,
Parkinson's disease

Exclusion Criteria:

Seizure
With metal implantation
Dementia or severe cognitive impairment

Sites / Locations

Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Experimental

Arm Label

High frequency rTMS plus fNIRS

Sham rTMS

High frequency rTMS

Arm Description

rTMS with neuroimage assessment of functional near infrared spectroscopy

Sham stimulation

High frequency rTMS to modulate brain areas

Outcomes

Primary Outcome Measures

Change of Repeatable Battery for the Assessment of Neuropsychological Status

Test cognition including memory, attention, language...

Secondary Outcome Measures

Change of Montreal Cognitive Assessment

Test cognition including memory, attention, and language.

Change of Fugl-Meyer Assessment , Wolf Motor Function Test

Test upper limb motor function.

Full Information

NCT ID

NCT02006615

First Posted

December 5, 2013

Last Updated

January 6, 2021

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT02006615

Brief Title

The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory

Official Title

The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory in Stroke, Parkinson, and Elderly Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 2, 2017 (Actual)

Primary Completion Date

July 11, 2021 (Anticipated)

Study Completion Date

July 11, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The investigators hypothesize that ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the function of primary motor cortex and prefrontal cortex that play key roles in motor and frontal memory processing.

Detailed Description

Excitatory (>3Hz) rTMS could facilitate the brain cortex and neuroplasticity that benefits motor control and working memory when the coil is applied over primary motor cortex or dorsolateral prefrontal gyrus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Nervous System Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High frequency rTMS plus fNIRS

Arm Type

Experimental

Arm Description

rTMS with neuroimage assessment of functional near infrared spectroscopy

Arm Title

Sham rTMS

Arm Type

Sham Comparator

Arm Description

Sham stimulation

Arm Title

High frequency rTMS

Arm Type

Experimental

Arm Description

High frequency rTMS to modulate brain areas

Intervention Type

Device

Intervention Name(s)

Functional near infrared spectroscopy

Other Intervention Name(s)

fNIRS

Intervention Description

Using high-sensitivity infrared to detect the active brain areas

Intervention Type

Device

Intervention Name(s)

rTMS

Intervention Description

To modulate brain cortex

Primary Outcome Measure Information:

Title

Change of Repeatable Battery for the Assessment of Neuropsychological Status

Description

Test cognition including memory, attention, language...

Time Frame

Up to 12 weeks

Secondary Outcome Measure Information:

Title

Change of Montreal Cognitive Assessment

Description

Test cognition including memory, attention, and language.

Time Frame

Up to 12 weeks

Title

Change of Fugl-Meyer Assessment , Wolf Motor Function Test

Description

Test upper limb motor function.

Time Frame

Up to 12 weeks

Other Pre-specified Outcome Measures:

Title

Change of hand grip, pinch power

Description

Test hand strength.

Time Frame

Up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ischemic or hemorrhagic cerebrovascular lesion, Parkinson's disease Exclusion Criteria: Seizure With metal implantation Dementia or severe cognitive impairment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Po-Yi Tsai, MD

Phone

886-228757293

vivitsai0518@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chih-Jou Lai, MD

Phone

886-228757361

milly1204@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Po-Yi Tsai, MD

Organizational Affiliation

Taipei Veterans General Hospital, Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Po-Yi Tsai, MD

Phone

886-228757293

vivitsai0518@gmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

34773596

Citation

Chang PW, Lu CF, Chang ST, Tsai PY. Functional Near-Infrared Spectroscopy as a Target Navigator for rTMS Modulation in Patients with Hemiplegia: A Randomized Control Study. Neurol Ther. 2022 Mar;11(1):103-121. doi: 10.1007/s40120-021-00300-0. Epub 2021 Nov 13.

Results Reference

derived

PubMed Identifier

32159313

Citation

Tsai PY, Lin WS, Tsai KT, Kuo CY, Lin PH. High-frequency versus theta burst transcranial magnetic stimulation for the treatment of poststroke cognitive impairment in humans. J Psychiatry Neurosci. 2020 Jul 1;45(4):262-270. doi: 10.1503/jpn.190060.

Results Reference

derived

PubMed Identifier

25218256

Citation

Lai CJ, Wang CP, Tsai PY, Chan RC, Lin SH, Lin FG, Hsieh CY. Corticospinal integrity and motor impairment predict outcomes after excitatory repetitive transcranial magnetic stimulation: a preliminary study. Arch Phys Med Rehabil. 2015 Jan;96(1):69-75. doi: 10.1016/j.apmr.2014.08.014. Epub 2014 Sep 11.

Results Reference

derived

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/23194830

Description

Document of rTMS effect in functional facilitation

URL

http://www.ncbi.nlm.nih.gov/pubmed/21980359

Description

Document of rTMS effect in functional facilitation

URL

http://www.ncbi.nlm.nih.gov/pubmed/19309294

Description

Document of rTMS effect in functional facilitation

Learn more about this trial

The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory

We'll reach out to this number within 24 hrs