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N/A Completed N=82 Randomized Double-blind Treatment

Brain Stimulation and Robotics in Chronic Stroke Motor Recovery

Source: ClinicalTrials.gov NCT03562663 ↗
Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Change From Baseline in Upper Limb Fugl Meyer Score — 7.0; 7.7 Units on a scale

Summary

Motor skill training and transcranial direct current stimulation (tDCS) have separately been shown to alter cortical excitability and enhance motor function in humans. Their combination is appealing for augmenting motor recovery in stroke patients, and this is an area presently under heavy investigation globally. The investigators have previously shown that the timing of tDCS application has functional significance, that tDCS applied prior to training can be beneficial for voluntary behavior, and that tDCS effects may not simply be additive to training effects, but may change the nature of the training effect. The investigators have separately reported in a randomized-controlled clinical trial, that upper limb robotic training alone over 12 weeks can improve clinical function of chronic stroke patients. Based on our results with tDCS and robotic training, the investigators hypothesize that the same repeated sessions of robotic training, but preceded by tDCS, would lead to a sustained and functional change greater than robotic training alone. The investigators will determine if clinical function can be improved and sustained with tDCS-robotic training and cortical physiology changes that underlie functional improvements.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Upper Limb Fugl Meyer Score
7.0; 7.7

Eligibility Criteria

Inclusion Criteria

  • A first single focal unilateral lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior;
  • Ability to follow 1-2 step commands
  • Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder and elbow and wrist).

Exclusion Criteria

  • A fixed contraction deformity in the affected limb;
  • A complete and total flaccid paralysis of all shoulder and elbow motor performance;
  • A hemorrhagic stroke
  • Presence of tDCS / TMS risk factors
  • Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
  • A history of medication-resistant epilepsy in the family
  • Past history of seizures or unexplained spells of loss of consciousness
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03562663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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