NCT02006615

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
3.5 years until next milestone

Study Start

First participant enrolled

June 2, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

4.1 years

First QC Date

December 5, 2013

Last Update Submit

January 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of Repeatable Battery for the Assessment of Neuropsychological Status

    Test cognition including memory, attention, language...

    Up to 12 weeks

Secondary Outcomes (2)

  • Change of Montreal Cognitive Assessment

    Up to 12 weeks

  • Change of Fugl-Meyer Assessment , Wolf Motor Function Test

    Up to 12 weeks

Other Outcomes (1)

  • Change of hand grip, pinch power

    Up to 12 weeks

Study Arms (3)

High frequency rTMS plus fNIRS

EXPERIMENTAL

rTMS with neuroimage assessment of functional near infrared spectroscopy

Device: Functional near infrared spectroscopyDevice: rTMS

Sham rTMS

SHAM COMPARATOR

Sham stimulation

Device: rTMS

High frequency rTMS

EXPERIMENTAL

High frequency rTMS to modulate brain areas

Device: rTMS

Interventions

Using high-sensitivity infrared to detect the active brain areas

Also known as: fNIRS
High frequency rTMS plus fNIRS
rTMSDEVICE

To modulate brain cortex

High frequency rTMSHigh frequency rTMS plus fNIRSSham rTMS

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic or hemorrhagic cerebrovascular lesion,
  • Parkinson's disease

You may not qualify if:

  • Seizure
  • With metal implantation
  • Dementia or severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Po-Yi Tsai, MD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 10, 2013

Study Start

June 2, 2017

Primary Completion

July 11, 2021

Study Completion

July 11, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01

Locations