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NCT Number: NCT02460809

Home-based Non-invasive Brain Stimulation and Hand Tracking Rehabilitation for People With Chronic Stroke

This is a device feasibility study, which will assess telerehabilitation in people with chronic stroke using a combination of noninvasive brain stimulation and finger tracking training. Telerehabilitation allows patients to train in their own home which also allows for longer training periods than what is currently allowed clinically. Noninvasive transcranial direct current stimulation (tDCS) uses two surface electrodes connected to a small battery that will be attached to the head. This will be used to modulate neuronal excitability. With sensors attached to fingers and the wrist, the patient will move the joints to track a target displayed on a screen. The combined treatment will be applied in two experiments. The first will be on 3 patients coming to our lab and the second on 3 patients in their home, both under supervision. We will integrate the two components and test the resulting and novel treatment system for technical feasibility, which will set the stage for future efficacy studies under federal grant support. We hypothesize that the developed system will be safe and feasible.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

This study will assess the feasibility of a telerehabilitation protocol involving non-invasive brain stimulation. Therefore, the two arms of the study are 1) implementation of this protocol in a controlled laboratory setting and 2) implementation of this protocol in a patient's home, being set up by the patient but controlled remotely using a blue-tooth system by an investigator in a different location. The two arms of this study will occur successively with the first arm being completed with three patients followed by the second arm being completed with a second group of three patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult at least 18 years old
  • stroke duration >6 months,
  • Mini-Mental State Examination score 24 or higher
  • presence of tactile sensation on the scalp
  • at least 10 degrees of active finger or wrist motion in the stroke hand
  • ability to walk 100 feet and transfer independently

Exclusion criteria

  • seizure within past two years
  • pregnancy
  • metal inside the had (dental metal is permitted)
  • implanted medical devices incompatible with tDCS

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

Transcranial direct current stimulation (tDCS) uses two surface electrodes placed on the scalp. These electrodes pass a low voltage current and modulate membrane potentials of underlying neurons.

Primary outcomes

  1. Digit Span

    Time frame: First day of study and one day following the final treatment

    Short-term memory test using single numerical digits

  2. Box and block

    Time frame: First day of study and one day following the final treatment

    Finger dexterity test using both paretic and nonparetic hands

  3. Quantification of Compliance Questionnaire

    Time frame: First day of study and one day following the final treatment

  4. User perception survey

    Time frame: First day of study and one day following the final treatment

    Survey

Secondary outcomes

  1. Survey of symptoms questionnaire

    Time frame: Each day of study as well as one day following the final treatment

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Home-based tDCS and Hand Tracking Rehabilitation for Chronic Stroke

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2015
Registry last updated
May 13, 2019

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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