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

NCT04646577 | Unknown DMC

• 1 other identifier: NEU0329
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Stroke; Stroke, Acute; Motor Function

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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

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

Secondary Outcomes (2)

• Sensory-motor function of the upper limb

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

• Degree of disability:

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

Study Arms (2)

Active

ACTIVE COMPARATOR

Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (tDCS

Sham

SHAM COMPARATOR

Device: Transcranial Direct Current Stimulation (tDCS

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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.

Active

Transcranial Direct Current Stimulation (tDCS DEVICE

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

Active; Sham

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• King Fahad Specialist Hospital Dammam: lead

Related Publications (1)

• 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.

  PMID: 33578615 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: November 30, 2020
• Study Start: December 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 30, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11