The Brain Injury Neurorehabilitation Project

NCT06556316 | Active Not Recruiting

• 2 other identifiers: Excellence/1216/0411Excellence/0918/0117
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of The Brain Injury Neurorehabilitation Project is a systematic effort to generate cutting edge research in brain injury and cognitive rehabilitation that will advance neurorehabilitation research. It will establish the first surveillance system and implement multimodal data to characterize the long-term effects of moderate to severe TBI. Additionally, the project will implement innovative rehabilitation methodologies, namely, cognitive training, social communication deficits and non-invasive brain stimulation with tDCS, to determine which modality can improve neurocognitive and psychosocial performance in adult ABI. Two funded projects, BRAIN-REHAB \& ACESO are incorporated in this project.

Conditions

Traumatic Brain Injury; CVA (Cerebrovascular Accident)

Keywords

ABI; CVA; Cognition; Psychosocial; Quality of life; TBI

Outcome Measures

Primary Outcomes (3)

• Memory

  The Greek version of the Auditory Verbal Learning Test will be used as a key outcome for memory. The test consists of a list of 15 items read to the participant, and the participant is required to recall as many items from the list. Maximum score per trial is 15. The process is repeated 5 times (presentation of the list and subsequent recall) for a possible maximum score of 60. A thirty-minute delay is also included after the five learning trials. The measure allows exploring a number of memory processes, such as short term memory (trial one), working memory (list learning across the five trials) and episodic memory (ability to recall items on the list after the 30-minute delay).

  Administered pre & post training at 3 & 6 months follow up

• Language

  Expressive and receptive language, including naming and verbal fluency, will be used. For this task, we will use the Greek short version of the Peabody Picture Vocabulary test (maximum score of 32) the Greek Short Version of the Boston Naming Test (maximum score of 20). In addition, animal naming in 60 seconds and words from letter F in 60 seconds will be used for verbal fluency. For all tasks, higher scores indicate better performance.

  Administered Pre and Post training at 3 & 6 months follow up

• Executive Functioning

  Laboratory and structured questionnaires will be used to assess executive functions. Laboratory tests include the Trail Making A and B (performance is measured in seconds; the faster, the better), and the Symbol Digits Modalities task (completion of as many items as possible in 90 seconds; higher score is better). In addition, the Dysexecutive Questionnaire will be completed by the participant and a close informant, to assess everyday executive functioning abilities. Maximum score is 148 and the lower score indicates better executive abilities.

  Administered pre & post training at 3 & 6 months follow up

Secondary Outcomes (2)

• WHO-BREF Quality of Life

  Adminsitered pre & post training at 3 & 6 months follow up

• Depression

  Adminisered pre & post training at 3 & 6 months follow up

Study Arms (6)

Patients with Moderate to Severe TBI who will receive cognitive rehabilitation

Adults with a history of moderate to severe TBI who will receive cognitive rehabilitation through the Categorization Program, a hierarchical remedial intervention

Behavioral: Cognitive Intervention with the Categorization Program

Patients with Moderate to Severe TBI who will receive psychosocial intervention

Adults with a history of moderate to severe TBI who will receive group intervention via the Social Cognitive Communication Program (SocCom)

Behavioral: Social Cognitive Communication Program

Patients with a history of CVA who will receive psychosocial intervention

Adults with a history of CVA (hemorrhagic or ischemic) who will receive group intervention via the Social Cognitive Communication Program (SocCom)

Behavioral: Social Cognitive Communication Program

Patients with a history of CVA who will receive psychosocial intervention and tDCS

Adults with a history of CVA (hemorrhagic or ischemic) who will receive group intervention via the Social Cognitive Communication Program (SocCom) and tDCS treatment

Behavioral: Social Cognitive Communication Program; Device: Non-Invasive Brain Stimulation with tDCS

Patients with TBI who will receive psychosocial intervention & TDCS

Adults with a history of moderate to severe TBI who will receive group intervention via the Social Cognitive Communication Program (SocCom) and tDCS treatment

Behavioral: Social Cognitive Communication Program; Device: Non-Invasive Brain Stimulation with tDCS

Patients with TBI receiving group psychosocial intervention and the Categorization Program

Adults with a history of moderate to severe TBI who will receive cognitive rehabilitation through the CP and group intervention with the SocCom treatment

Behavioral: Cognitive Intervention with the Categorization Program; Behavioral: Social Cognitive Communication Program

Interventions

Cognitive Intervention with the Categorization Program BEHAVIORAL

Cognitive intervention delivered individually. This is a hierarchical cognitive rehabilitation program

Also known as: CP

Patients with Moderate to Severe TBI who will receive cognitive rehabilitation; Patients with TBI receiving group psychosocial intervention and the Categorization Program

Social Cognitive Communication Program BEHAVIORAL

An 11 week group intervention targeting social and cognitive-communication abilities

Also known as: Soc Com

Patients with Moderate to Severe TBI who will receive psychosocial intervention; Patients with TBI receiving group psychosocial intervention and the Categorization Program; Patients with TBI who will receive psychosocial intervention & TDCS; Patients with a history of CVA who will receive psychosocial intervention; Patients with a history of CVA who will receive psychosocial intervention and tDCS

Non-Invasive Brain Stimulation with tDCS DEVICE

20 minute tDCS intervention as a non-invasive neuromodulation treatment

Also known as: tDCS Intervention

Patients with TBI who will receive psychosocial intervention & TDCS; Patients with a history of CVA who will receive psychosocial intervention and tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Survivors of ABI (TBI and CVA) who have been hospitalized and are at the chronic phases of their condition. They will be recruited from rehabilitation centers, patient advocacy groups and the major trauma hospital in Cyprus.

You may qualify if:

• moderate to severe TBI or hospitalization due to CVA

You may not qualify if:

• history of neurodevelopmental disorder, prior neurological history or psychiatric history requiring hospitalization

Sponsors & Collaborators

• University of Cyprus: lead

Study Sites (1)

University of Cyprus

Nicosia, 1678, Cyprus

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 16, 2024
• Study Start: July 1, 2020
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

CY (1)