The Effects of rTMS and tDCS Copuled With Robotic Therapy In Patients With Stroke

NCT05134324 | Unknown

• 1 other identifier: 22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of rTMS and tDCS coupled with robotic therapy on upper extremity functional recovery

Conditions

Chronic Stroke

Keywords

stroke; rTMS; tDCS; robotic therapy

Outcome Measures

Primary Outcomes (1)

• Upper Extremity Fugl-Meyer Motor Function Scale

  Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome.

  initial, 3th week 9th week changes

Secondary Outcomes (6)

• Motor Activity Log-28

  initial, 3th week 9th week changes

• Barthel Index

  initial, 3th week 9th week changes

• Stroke Impact Scale version 3.0

  initial, 3th week 9th week changes

• Box and Block Test

  initial, 3th week 9th week changes

• Modified Ashworth Scale

  initial, 3th week 9th week changes

Study Arms (4)

active rTMS

EXPERIMENTAL

Participants recevied 1 Hz low frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. The patient received robotic therapy for upper extremity just after each active TMS sessions

Other: active rTMS

sham rTMS

SHAM COMPARATOR

Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil. The patient received robotic therapy for upper extremity just after each sham TMS sessions

Other: sham rTMS

active tDCS

EXPERIMENTAL

Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions. The patient received robotic therapy for upper extremity just after each active tDCS sessions

Other: active tDCS

sham tDCS

SHAM COMPARATOR

Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions

Other: sham tDCS

Interventions

active rTMS OTHER

Participants recevied 1 Hz low frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. Motor threshold was defined as the minimum stimulus intensity eliciting 5 responses of about 50 µV out of 10 consecutive trials (50% successful MEPS) in the relaxed contralateral abductor pollicis brevis (APB).The patient received robotic therapy for upper extremity just after each active TMS sessions.

active rTMS

sham rTMS OTHER

Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil employed was identical in shape and size to the real stimulation coil and produced no magnetic field. The patient received robotic therapy for upper extremity just after each sham TMS sessions.

sham rTMS

active tDCS OTHER

Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions.The electrodes will be placed anodal to the C3/C4 (International 10/20 Electroencephalogram System) area, corresponding to the location of the affected hemisphere primary motor cortex (M1), and cathodal to the contralateral supraorbital region. The patient received robotic therapy for upper extremity just after each active tDCS sessions.

active tDCS

sham tDCS OTHER

Participants recevied sham stimulation were applied current was ramped up either over 10 seconds, with an equal amount of time for tapering off. The patient received robotic therapy for upper extremity just after each sham tDCS sessions

sham tDCS

Eligibility Criteria

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

You may qualify if:

• ischemic stroke with a disease interval of 6 months to 2 years
• aged based 18 years
• first stroke
• Mini mental test score ≥ 22
• upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS)≤2
• Shoulder, elbow and wrist muscle strength ≥ 2 according to Medical Research Council- MRC

You may not qualify if:

• hemorrhagic stroke
• history of epilepsy
• a cardiac pacemaker
• pregnancy
• Fugl Meyer upper extremity assessment score ≥44
• history of previous stroke or ischemic attack
• neurological diseases other than stroke
• metallic implant in brain or scalp (including cochlear implant)
• previous brain surgery
• orthopedic disease that prevents upper extremity movements
• diagnosis of malignancy
• receiving robotic /TMS/tDCS treatments in the last 6 months

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Esra Celik Karbancioglu, MD

  SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 24, 2021
• Study Start: May 25, 2021
• Primary Completion: February 25, 2022
• Study Completion: May 25, 2022
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)