baclofen intratecale oscabi retrospettivo

The intra‐The intra‐thecal baclofen thecal baclofen in the patients in the patients with severe brain injury:with severe brain injury: an Italian multicentric stan Italian multicentric study. udy.

Mauro ZampoliniDepartment of RehabilitationASL3 – Regione Umbria - Italy

Implant of Baclofen Implant of Baclofen PumpPump

11/28/2008 2ROMA - Istituto Santa Lucia

OSCABI - R projectOSCABI - R project• Retrospective data collection about Italian

experience in the treatment of spasticity in patients affected by severe acquired brain injury and implanted with a pump

• 184 patients included• Whole population has been divided into two

subgroups:

–Patients with non vascular, both traumatic and non traumatic severe brain injury (140 pts)

–Patients with vascular severe brain injury (44 pts)

11/28/2008 3

Baseline Implant of pump Last follow-up available

ROMA - Istituto Santa Lucia

4

Participating CenterParticipating Center

1. Centro Cardinal Ferrari, Fontanellato, Italy 2. Ospedale di Circolo e Fondazione Macchi, Neurosurgery,

Varese, Italy3. Montecatone Rehabilitation Institute, Spinal Cord Unit, Imola,

Italy4. Az. Osp. “G. Salvini”, NeuroRehabilitation, Garbagnate Milanese,

Italy5. Presidio Ospedaliero di Vicenza, Spinal Cord Unit, Vicenza, Italy6. Ospedale Sacro Cuore- Don Calabria, Rehabilitation division,

Negrar, Italy7. Ospedale Civile Franchini, Rehabilitation, Santarcangelo di

Romagna, Italy8. Presidio Ospedaliero Ausiliatrice, Torino, Italy9. Villa Beretta, Costamasnaga, Italy10.Ospedale San Carlo e Donnino, Pergola, Italy11.Fondazione Salvatore Maugeri, Rehabilitation, Telese Terme,

Italy12.Presidio Ospedaliero Unico Versilia, Rehabilitation, Lido di

Camaiore, Italy13.Villa Rosa, Spinal Cord Unit, Pergine Valsugana, Italy14.Osp.Riuniti Umberto I-Lancisi-Salesi, Spinal Cord Unit, Ancona,

Italy15.Ospedale Santa Maria della Misericordia, Rehabilitation, Udine,

Italy16.Presidio Cisanello, Rehabilitation, Pisa, Italy 17.Istituto di riabilitazione, Trevi, Italy18.Ospedale Eugenio Morelli, Neuro-rehabilitation, Sondalo, Italy19.Ospedale della Misericordia, Rehabilitation, Grosseto, Italy20.Fondazione Santa Lucia, Neuro-rehabilitation, Roma, Italy21.Ospedale Cannizzaro, Catania, Italy

1. Centro Cardinal Ferrari, Fontanellato, Italy 2. Ospedale di Circolo e Fondazione Macchi, Neurosurgery,

Varese, Italy3. Montecatone Rehabilitation Institute, Spinal Cord Unit, Imola,

Italy4. Az. Osp. “G. Salvini”, NeuroRehabilitation, Garbagnate Milanese,

Italy5. Presidio Ospedaliero di Vicenza, Spinal Cord Unit, Vicenza, Italy6. Ospedale Sacro Cuore- Don Calabria, Rehabilitation division,

Negrar, Italy7. Ospedale Civile Franchini, Rehabilitation, Santarcangelo di

Romagna, Italy8. Presidio Ospedaliero Ausiliatrice, Torino, Italy9. Villa Beretta, Costamasnaga, Italy10.Ospedale San Carlo e Donnino, Pergola, Italy11.Fondazione Salvatore Maugeri, Rehabilitation, Telese Terme,

Italy12.Presidio Ospedaliero Unico Versilia, Rehabilitation, Lido di

Camaiore, Italy13.Villa Rosa, Spinal Cord Unit, Pergine Valsugana, Italy14.Osp.Riuniti Umberto I-Lancisi-Salesi, Spinal Cord Unit, Ancona,

Italy15.Ospedale Santa Maria della Misericordia, Rehabilitation, Udine,

Italy16.Presidio Cisanello, Rehabilitation, Pisa, Italy 17.Istituto di riabilitazione, Trevi, Italy18.Ospedale Eugenio Morelli, Neuro-rehabilitation, Sondalo, Italy19.Ospedale della Misericordia, Rehabilitation, Grosseto, Italy20.Fondazione Santa Lucia, Neuro-rehabilitation, Roma, Italy21.Ospedale Cannizzaro, Catania, Italy

11/28/2008 ROMA - Istituto Santa Lucia

Aim of the studyAim of the studyobservational perspective studyobservational perspective study

Primary goal◦evaluate the effect of ITB in

patients affected by severe acquired brain injury

Secondary goals◦Safety of treatment ◦Adverse events


Inclusion criteriaInclusion criteria

Patients affected by traumatic and non-traumatic acquired brain injury

Patients who underwent to a implant of a programmable pump between January 1994 and January 2007


Demographic Demographic characteristicscharacteristics

184 patients enrolled in 21 Italian Centers between 1994 and 2007


8

AetiologyAetiology

Mean age 39 years (± 14, range 5 - 76 years)


11/28/2008 ROMA - Istituto Santa Lucia 9

Distribution of the age

GeneralGeneral Characteristics Characteristics

10

•Timing of treatment• Mean timing between event and implant

23 months23 months (range 3 - 156 months)

•Timing of follow-up• Mean timing between implant and follow

up: 28 months28 months (range 1 - 144 months)


Drugs Used before the ITB Drugs Used before the ITB therapytherapy


Baclofen testBaclofen test


Type of Baclofen testType of Baclofen test


G.O.S. (Glasgow Outcome G.O.S. (Glasgow Outcome Scale)Scale)

0%

76%

22%

2% 0%1%

46% 46%

6%1%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5

Baseline

Follow up


0%

46% 46%

8%

0%0%

23%

57%

18%

2%0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5

Baseline

Follow up

Bra

in I

njur

yS

trok

e

Ashworth scale – Brain Ashworth scale – Brain InjuryInjury

2% 1%7%

50%

40%

7%

30% 29%24%

10%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5

% o

f p

atie

nts

Ashworth scale

Baseline

Follow up

15

4%1%

4%

44%47%

11%

28%31%

21%

9%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5

% o

f p

atie

nts

Ashworth scale

Baseline

Follow up

Upper limbs

Lower limbs


Ashworth scale - Ashworth scale - strokestroke

0%

13%18%

44%

25%

11%

31%

42%

11%5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5%

of

pa

tie

nts

Ashworth scale

Baseline

Follow up

16

0%7%

11%

41% 41%

11%

38%42%

9%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5

% o

f p

atie

nts

Ashworth scale

Upper limbs

Lower limbs


Spasms scale – Brain InjurySpasms scale – Brain Injury

36%

6%

23%27%

8%

75%

10% 10%5%

0%0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4

% o

f p

atie

nts

Spasms score

Baseline

Follow up


34%

5%

25%22%

14%

84%

7% 7%2% 0%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4

% o

f p

atie

nts

Spasms score

Baseline

Follow up

Brain InjuryBrain Injury

StrokeStroke

Goals expected from the Goals expected from the implantimplant

1%

9%

24%

47%

52%

88%

91%

0% 20% 40% 60% 80% 100%

Decrease of neurovegetative crisis

Mobility improvement

Improvement in activites of daily life (ADLs)

Decrease of pain

Improvement in rehabilitation

Nursing

Prevention of deformities/contractures


Objectives reachedObjectives reached

31%

28%

31%

31%

16%

28%

100%

69%

72%

69%

69%

84%

72%

0% 20% 40% 60% 80% 100%

Decrease of neurovegetative crisis

Mobility improvement

Improvement in activites of daily life (ADLs)

Decrease of pain

Facility in rehabilatation

Nursing

Prevention of deformities/contractures

Not reached

Partially/Totally reached


Satisfaction questionnaireSatisfaction questionnaire

86% of Care-givers were satisfied with the implant and would choose it again

76% of collaborative patients were satisfied with the implant and would do it again


Adverse events related to intrathecal Adverse events related to intrathecal baclofenbaclofen

20 patients of patients experienced 34 adverse events

Adverse event Incidence Treatment

Diarrhoea, insomnia, sweating 0,7% (1pt) Spontaneously solved

Coma 0,7%(1pt) Decrease of baclofen dosage

Loss of coordination, constipation 0,7%(1pt) Decrease of baclofen dosage

Tolerance 0,7%(1pt) Decrease of baclofen dosage

Withdrawal symptoms 1% (2pts) Refill

Weakness 1% (2pts) Decrease of baclofen dosage

Nausea / vomiting 1% (2pts) Medical treatment

Hypotension 2% (4pts) Decrease of baclofen dosage

Epileptic crisis 3% (7pts)Medical treatment in 4 cases

Critical care in one case

Drowsness 4% (12pts)Spontaneously solved

or decrease of baclofen dosage

Urine retention 2% (1pt) Medical treatment


Adverse events related to deviceAdverse events related to device

6 patients of patients experienced 8 adverse events

Adverse event Incidence Treatment

Pocket seroma 1% (2 pts)Medical treatment in one case

Pump replacement in one case

Subcutaneous haematoma 1% (2 pts) Medical treatment

Infection 0,7% (1pt) Antibiotic therapy

Catheter migration 0,7% (1pt) Catheter replacement

Malfunction of pump 0,7% (1 pt) Pump replacement

Increase in spasticity close to refill

2% (1pt) Refill


ConclusionsConclusions

• Significant decrease of spasticity and spasms

• Objectives awaited from the treatments reached in most of patients

• Care-giver and patient satisfaction

• Low rate of adverse events (underestimated)


Limits of this studyLimits of this study

Retrospective studySome data missedHeterogeneous follow up timing

No analytics functional scales.


Future…………Future…………• OSCAPI – P study

• Prospective study on patients affected by severe acquired brain injury.

• At the moment 39 Italian centres involved and 56 patients enrolled.

• One year of follow up

• European RCT study (ITB and Stroke)• Final definition of the protocol Sisters RCT single

blinded


baclofen intratecale oscabi retrospettivo

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