Virtual reality with brain stimulation to help arm recovery after stroke

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had their first ischemic stroke and have mild to moderate arm weakness. It tests a virtual reality arm training with brain stimulation.

Age

Over 18 and under 80 years.

Sex

All sexes can join.

Disease stage

First ever ischemic stroke with mild to moderate movement problems of the arm. Lesion in the middle cerebral artery area, on the left or right side. Fugl-Meyer score below 56.

Earlier treatment

Cannot have been treated with Benzodiazepines or Baclofen.

Main reasons for not taking part

• History of seizures
• Pregnancy
• Metal implant inside the skull or a cardiac pacemaker
• Arm pain or an orthopedic limitation of the arm
• Other neurological, neuropsychiatric or neuropsychological disorders that could affect consent or compliance

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 80 years old?YesNo

What the trial wants to find out

The investigators hypothesize that a myoelectric (EMG) controlled virtual reality (VR) interface allows for effective upper limb motor recovery of stroke patients. EMG control offers the possibility to alter visual feedback according to the recorded muscle activity in real-time. By manipulating the motion of a virtual hand associated with the recorded muscle patterns, assistance can be provided to stroke patients by correcting the error between the actual (dysfunctional) and a reference (functional) muscle pattern. Thus, through such an assistive EMG control algorithm, patients will be able to perform reaching movements with the virtual hand despite their motor impairment. By gradually reducing assistance, it is hypothesized that the salient error in the task space provided as visual feedback will systematically change the muscle patterns, thereby driving adaptation of the dysfunctional muscle patterns, enhancing motor recovery. Moreover, due to its relevant role in motor learning, it is expected that cerebellar stimulation will favor the underlying processes of adapting cerebello-cortical plasticity involved in motor learning. Therefore, it is hypothesized that an assistive EMG control algorithm in combination with cerebellar transcranial magnetic stimulation will further enhance upper limb recovery.

The 3 groups in the trial

• EMG-VR real c-iTBSTreatment being tested

  Subjects will perform 12 sessions (\~30 minutes, 3 times per weeks for 4 weeks) of assisted EMG control task (aEC) after real cerebellar intermittent theta burst stimulation (c-iTBS) for paretic upper limb.

  Treatment: Virtual Reality Interface + Cerebellar iTBS (c-iTBS)

• EMG-VR sham c-iTBSSham treatment, for comparison

  Subjects will perform 12 sessions (\~30 minute, 3 times per weeks for 4 weeks) of assisted EMG control task (aEC) after sham cerebellar intermittent theta burst stimulation (c-iTBS) for paretic upper limb.

  Treatment: Virtual Reality + Sham Cerebellar iTBS (sham c-iTBS)

• Conventional Physical TherapyExisting treatment, for comparison

  Subjects will perform 12 sessions (\~30 minutes, 3 times per weeks for 4 weeks) of physical therapy targeting on motor functionality of upper limb.

  Treatment: Physical Therapy