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The Effect of tDCS Combined With Functional Task Training on Motor Recovery in Stroke Patients

Primary Purpose

Stroke, Stroke, Acute, Motor Function

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Repetitive Transcranial Magnetic Stimulation (rTMS)

Transcranial Direct Current Stimulation (tDCS

About this trial

This is an interventional basic science trial for Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age 18-90
first-time clinical ischemic or hemorrhagic cerebrovascular accident as noted in the radiological (or physician's) report;
the ability to extend =20° at the wrist and 10° at the metacarpophalangeal and interphalangeal joints of all digits;
participants must demonstrate adequate balance while wearing the restraint;
the ability to stand from a sitting position and the ability to stand for at least 2 minutes with or without upper extremity support;
weakness, defined as score of 15-55 (out of 66) on arm motor Fugl-Meyer (FM) scale; and
stroke onset more then 6 months prior to study enrollment.

Exclusion Criteria:

significant pre-stroke disability;
where applicable (a history of depression before the stroke);
any substantial decrease in alertness, language reception, or attention that might interfere with understanding the instructions for the motor testing;
excessive pain in any joint of the paretic extremity;
contraindications to single-pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants;
advanced liver, kidney, cardiac, or pulmonary disease;
a terminal medical diagnosis consistent with survival 1 year;
coexistent major neurological or psychiatric disease (to decrease the number of confounders);
a history of significant drug abuse in the prior 6 months;
the use of certain neuropsychotropic drugs such as tricyclics, antidepressants, or 51 of 66 carbamazepine;
active enrollment in a separate intervention study targeting stroke recovery; (
previously applied constraint-induced motor therapy and/or tDCS treatment for stroke; and
a history of epilepsy before stroke (or episodes of seizures within the last six months).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active

Sham

Arm Description

Outcomes

Primary Outcome Measures

To assess the neurophysiologic findings of cortical plasticity.

Expressed as percent motor resting threshold and numerical values of motor evoked potential. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould). The percentage of inhibition or facilitation for each before and after stimulation will be calculated.

To assess the motor function changes .

Change from motor hand function: ordinal variable measured through the Jebsen-Taylor Hand Function Test (JTHFT). The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects

Secondary Outcome Measures

Sensory-motor function of the upper limb

This consists of a quantitative scale developed to measure (motor recovery, balance, sensation, and some joint function) recovery of the motor function of stroke patients. Measured through the Fugl-Meyer Rating Scale, which expressed in values from 0 to 66.

Degree of disability:

This consists of a quantitative scale developed to measured the disability caused by impairments in stroke patients. The Barthel Index Score (Activities of Daily Living) measured through ranges from 0 to 20, principally concerned with physical aspects of disability.

Full Information

NCT ID

NCT04646577

First Posted

October 6, 2020

Last Updated

November 22, 2020

Sponsor

King Fahad Specialist Hospital Dammam

1. Study Identification

Unique Protocol Identification Number

NCT04646577

Brief Title

The Effect of tDCS Combined With Functional Task Training on Motor Recovery in Stroke Patients

Official Title

The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2020 (Anticipated)

Primary Completion Date

May 1, 2021 (Anticipated)

Study Completion Date

May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

King Fahad Specialist Hospital Dammam

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

We propose to enhance the effects of brain plasticity using a powerful noninvasive technique for brain modulation consisting of navigated transcranial magnetic stimulation (TMS) priming with transcranial direct current stimulation (tDCS) in combination with motor-training-like constraint-induced movement therapy (CIMT).

6. Conditions and Keywords

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

Stroke, Stroke, Acute, Motor Function

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Masking Description

Double (Participant, Outcomes Assessor)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Active Comparator

Arm Title

Sham

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Description

Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous) prime with anodal Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint induced movement therapy. Each session will last 20 minutes.

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation (tDCS

Intervention Description

Subjects will either undergo sham Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint-induced movement therapy.

Primary Outcome Measure Information:

Title

To assess the neurophysiologic findings of cortical plasticity.

Description

Time Frame

Before 10 sessions, before and after each session (every day), after 10 daily sessions and after 6 weeks

Title

To assess the motor function changes .

Description

Time Frame

before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days

Secondary Outcome Measure Information:

Title

Sensory-motor function of the upper limb

Description

Time Frame

before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days

Title

Degree of disability:

Description

Time Frame

before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 18-90 first-time clinical ischemic or hemorrhagic cerebrovascular accident as noted in the radiological (or physician's) report; the ability to extend =20° at the wrist and 10° at the metacarpophalangeal and interphalangeal joints of all digits; participants must demonstrate adequate balance while wearing the restraint; the ability to stand from a sitting position and the ability to stand for at least 2 minutes with or without upper extremity support; weakness, defined as score of 15-55 (out of 66) on arm motor Fugl-Meyer (FM) scale; and stroke onset more then 6 months prior to study enrollment. Exclusion Criteria: significant pre-stroke disability; where applicable (a history of depression before the stroke); any substantial decrease in alertness, language reception, or attention that might interfere with understanding the instructions for the motor testing; excessive pain in any joint of the paretic extremity; contraindications to single-pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants; advanced liver, kidney, cardiac, or pulmonary disease; a terminal medical diagnosis consistent with survival 1 year; coexistent major neurological or psychiatric disease (to decrease the number of confounders); a history of significant drug abuse in the prior 6 months; the use of certain neuropsychotropic drugs such as tricyclics, antidepressants, or 51 of 66 carbamazepine; active enrollment in a separate intervention study targeting stroke recovery; ( previously applied constraint-induced motor therapy and/or tDCS treatment for stroke; and a history of epilepsy before stroke (or episodes of seizures within the last six months).

12. IPD Sharing Statement

Citations:

PubMed Identifier

33578615

Citation

Al-Hussain F, Nasim E, Iqbal M, Altwaijri N, Asim N, Yoo WK, Bashir S. The effect of transcranial direct current stimulation combined with functional task training on motor recovery in stroke patients. Medicine (Baltimore). 2021 Feb 12;100(6):e24718. doi: 10.1097/MD.0000000000024718.

Results Reference

derived

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The Effect of tDCS Combined With Functional Task Training on Motor Recovery in Stroke Patients

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