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OpenTrials
Completed

NCT Number: NCT01850836

Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia

To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic stimulation (rTMS) on post-stroke non fluent aphasia.

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Key information

Conditions

Non Fluent Aphasia in Subacute Stroke Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Thirty patients with subacute post-stroke non-fluent aphasia were randomly allocated with a ratio 2:1 to receive real (n = 20) or sham (n = 10) rTMS of the affected motor cortex. Each patient received 1000 rTMS pulses (1 Hertz at 110% of resting motor threshold) over the unaffected Broca's area and 1000 pulses (20 Hertz at 100% resting motor threshold) over affected left Broca's area for 10 consecutive days. LANGUAGE section of hemispheric stroke scale, Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H) and NIH stroke scale were assessed before, post sessions, 1 and 2 months after the last session . Motor threshold was assessed before and after the end of last session.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • acute hemiplegia with non-fluent aphasia, single thromboembolic non-haemorrhagic infarction documented by computerized tomography (CT) in the distribution of middle cerebral artery.

Exclusion criteria

  • head injury or neurological disease other than stroke,
  • Unstable cardiac dysrhythmia,
  • Fever,
  • Infection,
  • Hyperglycaemia
  • Prior administration of tranquilizer
  • Patients with no motor evoked response recorded from first dorsal interosseus (FDI) muscle of the affected hand

Treatment and study plan

repetitive transcranial magnetic stimulation

Procedure

Other names: rTMS

Primary outcomes

  1. Hemispheric stroke scale (HSS)

    Time frame: Change from Baseline in HSS at 2 months

    Language assessment using hemispheric stroke scale (HSS)

Secondary outcomes

  1. NIH Stroke Scale (NIHSS)

    Time frame: Change from Baseline in NIHSS at 2 months

Other outcomes

  1. Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H)

    Time frame: Change from Baseline in SADQ-H at 2 months

    (Asking about presence of depressive symptoms within last week of stroke to be present all the days or frequent from 4-6 days, or infrequent from 1-4 days, or not at all).

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Treatment of Aphasic Stroke Patients With rTMS

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 10, 2013
Registry last updated
May 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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