Stroke Clinical Trial
— TSOfficial title:
A Prospective Observational Study on Risk Factors of Developing and Prevalence of Trephined Syndrome in Patients After Hemispheric Decompressive Craniectomy and Effect of Cranioplasty on Functional and Cognitive Recovery
Verified date | November 2020 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Decompressive craniectomy is frequently used to treat increased intracranial pressure or an intracranial mass effect. Trephined Syndrome describes a neurological deterioration, which is attributed to a large craniectomy. The symptomatology is varied but includes headache, aggravation of a hemisyndrome or cognitive disorders, often has an orthostatic component and improves or disappears with cranioplasty. The incidence of Trephined Syndrome has been reported between 7% and 26%. However, it might be underestimated if the course of cognitive functions before and after cranioplasty were insufficiently documented.
Status | Terminated |
Enrollment | 41 |
Est. completion date | March 31, 2017 |
Est. primary completion date | March 31, 2017 |
Accepts healthy volunteers | |
Gender | All |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: - Patients with decompressive craniectomy for intracranial hypertension secondary to stroke, traumatic brain injury or other non-progressive cerebral pathology. Exclusion Criteria: - patients suffering from a rapidly evolving cerebral pathology (e.g. tumor) - patients transferred to other hospitals before cranioplasty or whose follow-up can not be assured. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Neuro-Rehabilitation Division, University Hospital of Geneva | Genève |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
Akins PT, Guppy KH. Sinking skin flaps, paradoxical herniation, and external brain tamponade: a review of decompressive craniectomy management. Neurocrit Care. 2008;9(2):269-76. Review. — View Citation
Beauchamp KM, Kashuk J, Moore EE, Bolles G, Rabb C, Seinfeld J, Szentirmai O, Sauaia A. Cranioplasty after postinjury decompressive craniectomy: is timing of the essence? J Trauma. 2010 Aug;69(2):270-4. doi: 10.1097/TA.0b013e3181e491c2. — View Citation
Bijlenga P, Zumofen D, Yilmaz H, Creisson E, de Tribolet N. Orthostatic mesodiencephalic dysfunction after decompressive craniectomy. J Neurol Neurosurg Psychiatry. 2007 Apr;78(4):430-3. Epub 2006 Nov 21. — View Citation
Chang V, Hartzfeld P, Langlois M, Mahmood A, Seyfried D. Outcomes of cranial repair after craniectomy. J Neurosurg. 2010 May;112(5):1120-4. doi: 10.3171/2009.6.JNS09133. — View Citation
Dujovny M, Agner C, Aviles A. Syndrome of the trephined: theory and facts. Crit Rev Neurosurg. 1999 Sep 24;9(5):271-278. — View Citation
Fodstad H, Love JA, Ekstedt J, Fridén H, Liliequist B. Effect of cranioplasty on cerebrospinal fluid hydrodynamics in patients with the syndrome of the trephined. Acta Neurochir (Wien). 1984;70(1-2):21-30. — View Citation
Honeybul S. Complications of decompressive craniectomy for head injury. J Clin Neurosci. 2010 Apr;17(4):430-5. doi: 10.1016/j.jocn.2009.09.007. Epub 2010 Feb 23. — View Citation
Joseph V, Reilly P. Syndrome of the trephined. J Neurosurg. 2009 Oct;111(4):650-2. doi: 10.3171/2009.3.JNS0984. — View Citation
Kemmling A, Duning T, Lemcke L, Niederstadt T, Minnerup J, Wersching H, Marziniak M. Case report of MR perfusion imaging in sinking skin flap syndrome: growing evidence for hemodynamic impairment. BMC Neurol. 2010 Sep 11;10:80. doi: 10.1186/1471-2377-10-80. — View Citation
Mokri B. Orthostatic headaches in the syndrome of the trephined: resolution following cranioplasty. Headache. 2010 Jul;50(7):1206-11. doi: 10.1111/j.1526-4610.2010.01715.x. Epub 2010 Jun 18. — View Citation
Ng D, Dan NG. Cranioplasty and the syndrome of the trephined. J Clin Neurosci. 1997 Jul;4(3):346-8. — View Citation
Sarov M, Guichard JP, Chibarro S, Guettard E, Godin O, Yelnik A, George B, Bousser MG, Vahedi K; DECIMAL investigators. Sinking skin flap syndrome and paradoxical herniation after hemicraniectomy for malignant hemispheric infarction. Stroke. 2010 Mar;41(3):560-2. doi: 10.1161/STROKEAHA.109.568543. Epub 2010 Jan 7. — View Citation
Schiffer J, Gur R, Nisim U, Pollak L. Symptomatic patients after craniectomy. Surg Neurol. 1997 Mar;47(3):231-7. Review. — View Citation
Stiver SI, Wintermark M, Manley GT. Reversible monoparesis following decompressive hemicraniectomy for traumatic brain injury. J Neurosurg. 2008 Aug;109(2):245-54. doi: 10.3171/JNS/2008/109/8/0245. — View Citation
Stiver SI. Complications of decompressive craniectomy for traumatic brain injury. Neurosurg Focus. 2009 Jun;26(6):E7. doi: 10.3171/2009.4.FOCUS0965. Review. — View Citation
Thavarajah D, De Lacy P, Hussien A, Sugar A. The minimum time for cranioplasty insertion from craniectomy is six months to reduce risk of infection--a case series of 82 patients. Br J Neurosurg. 2012 Feb;26(1):78-80. doi: 10.3109/02688697.2011.603850. Epub 2011 Oct 5. — View Citation
Yadla S, Campbell PG, Chitale R, Maltenfort MG, Jabbour P, Sharan AD. Effect of early surgery, material, and method of flap preservation on cranioplasty infections: a systematic review. Neurosurgery. 2011 Apr;68(4):1124-9; discussion 1130. doi: 10.1227/NEU.0b013e31820a5470. Review. — View Citation
Yang XF, Wen L, Shen F, Li G, Lou R, Liu WG, Zhan RY. Surgical complications secondary to decompressive craniectomy in patients with a head injury: a series of 108 consecutive cases. Acta Neurochir (Wien). 2008 Dec;150(12):1241-7; discussion 1248. doi: 10.1007/s00701-008-0145-9. Epub 2008 Nov 13. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of Trephined Syndrome | To determine the incidence and severity of the the Trephined Syndrome in relation to delay to cranioplasty. | From patients admission to discharge from rehabilitation (approx. 3 months). | |
Secondary | Complications related to cranioplasty | To record the incidence of complications, such as hemorrhagic or infectious, related to cranioplasty intervention. | From patients admission to discharge from rehabilitation (approx. 3 months). | |
Secondary | Relation of delay to cranioplasty with neurological outcome | To investigate the relationship between cranioplasty delay and neurological outcome | From patients admission to discharge from rehabilitation (approx. 3 months). | |
Secondary | Relation of delay to cranioplasty with complications post-cranioplasty | To investigate the relationship between cranioplasty delay and complication rate | From patients admission to discharge from rehabilitation (approx. 3 months). |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |