Implanted (brain) Stimulators to Augment stroke Rehabilitation Therapy (iSTART trial)

Phase 1

Recruiting

• Conditions: Stroke; Neurological - Other neurological disorders; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12616000029493
• Lead Sponsor: Ministry of Business, Innovation and Employment

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Aged at least 18 years on the day of consent
2. capable of understanding and signing an informed consent form
3. have a cortical or subcortical stroke at least 4 months earlier, screened by prior CT/MRI and verified by study MRI
4. been assessed by physiotherapy and deemed suitable (UEFM 20 to 50-moderate to mild upper limb function; Motor Assessment Scale: 2/6 on the Upper Arm Function scale; likely to be able to participate in 80% or more of the 12 weeks of daily physiotherapy post-surgery sessions)
5. suitable and fit for surgery

Exclusion Criteria

1. history of epileptic seizures
2. participants with pacemakers/defibrillators
3. participants who have contraindications for MRI and TMS
4. female participants who are or intend to become pregnant
5. participants who, in the opinion of the investigators, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved)
6. participants who have pain, significant musculotendinous or bony restrictions of the affected upper limb, chronic disease (other than stroke) that will independently cause significant disability or weakness of the affected upper limb
7. any participant for whom the investigators believe, for any reason, that participation would not be an acceptable risk
8. patients in whom any anticoagulation treatment cannot be transiently stopped in the preoperative period, analogous to what is done in the routine brain surgery (5 to 10 days stop before the surgery, and 2 days postoperatively, depending on the medication use)

Study & Design

• Study Type: Interventional
• Study Design: Not specified