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Table 1  Flow chart of visits and events

From: Brain‐oscillation-synchronized stimulation to enhance motor recovery in early subacute stroke: a randomized controlled double‐blind three‐ arm parallel‐group exploratory trial comparing personalized, non‐ personalized and sham repetitive transcranial magnetic stimulation (Acronym: BOSS-STROKE)

Events

Screening (V1)-14 days to -1 day prior 1th treatment

Treatment (V2-6) (treatment will be performed on 5 following working days)

Post –treatment (V7)g (last treatment and post- treatment visit will be performed on the same day)

Follow-up (V8)g(after 3 months ± 7 days)

Study Entry

 Informed Consent (IC)

X

–

–

–

 Inclusion/Exclusion Criteria

X

–

–

–

 Physical and neurological examination

X

–

–

–

 Medical History

X

–

–

–

 Pre-treatment clinical assessmenta

Xf

–

–

–

 TMS and EEG measurementb

Xf

–

–

–

 MRIc

X

–

–

–

 Randomizationd

X

–

–

–

 TMS and physiotherapy sessions

–

X

–

–

 Post-treatment assessmenta

–

–

X

–

 Post-treatment follow-up assessment e

–

–

–

X

 Adverse Events

–

Start of study treatment or after first treatment and until 7 days after discontinuation from treatment

  1. apre & post treatment assessment and tests: Fugl‐Meyer Assessment upper extremity (FMA-UE); grip strength; SS‐QOL; Rankin Scale; Barthel Index. For screening, FMA-UE and grip strength should be repeated within 3 days prior first treatment (V2), if the screening was done earlier
  2. bEach center will send the EEG raw (32‐channel) data to the coordinating center. It is sufficient that appropriate data from a standard EEG measurement is available. This can also be from an examination before screening
  3. cMRI is not mandatory for inclusion, but a sufficient imaging should be available before start of treatment (please
  4. see section “screening visit V1” for more details)
  5. din case of eligibility the randomization will take place at the end of the screening
  6. epost treatment follow-up assessment and tests: FMA-UE; grip strength; SS‐QOL; modified Rankin Scale; Barthel Index; number of days as an inpatient during the 3 months after the intervention
  7. f TMS, EEG (32‐channel) and Pre‐treatment clinical assessment at screening should be repeated within 3 days prior first treatment (V2), if done earlier. Standard EEG is not relevant for inclusion and can be performed at any time, also before screening
  8. gPerformed by a blinded rater
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BMC Neurology

ISSN: 1471-2377

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